Healthy VolunteersPhase 1NCT03058237
A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
A Phase 1 study testing Arbaclofen Placarbil SR, Arbaclofen Placarbil MR Prototype A and Arbaclofen Placarbil MR Prototype B in people with Healthy Volunteers, run by Indivior Inc. at 1 site in United Kingdom.
Trial summary
Part 1 To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects To determine the relative bioavailability of AP and R-baclofen following… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Arbaclofen Placarbil SR, Arbaclofen Placarbil MR Prototype A and Arbaclofen Placarbil MR Prototype B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2017to 5 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 30.0 kg/m^2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent prior to any study-specific procedures
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any clinically significant drug/substance or alcohol abuse or disorders in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Regular alcohol consumption <5 units per week on average
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- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and each admission
- Current smokers of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
- Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 IU/L)
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Clinically significant abnormal ECG as judged by the investigator, including a QT interval corrected using Fridericia's formula of >450 msec in males and >470 msec in females
- Positive drugs of abuse test result at screening and each admission (drugs of abuse tests are listed in the protocol)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <70 mL/min using the Cockcroft-Gault equation
- History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease or psychiatric disorder, as judged by the investigator
- History of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (eg, Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past 2 years, or currently receiving anticonvulsant therapy for any reason
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraceptives) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Part 1
- To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects
- To determine the relative bioavailability of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype A Tablet and Arbaclofen Placarbil MR Prototype B Tablet compared to the reference Arbaclofen Placarbil Sustained Release (SR) Tablets (low dose)
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of the selected MR prototype formulation(s) in the presence of beverage
- To provide additional information on the safety and tolerability of single doses of AP
Read more
Part 2
- To evaluate the PK profile of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype Tablets in healthy subjects
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype Tablets compared to the reference Arbaclofen Placarbil Immediate Release (IR) Capsule
- To provide additional information on the safety and tolerability of single doses of AP
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of a selected MR prototype formulation in the fed state (optional)
- To explore a possible in vitro in vivo correlation/relationship (IVIVC/IVIVR) for the Arbaclofen Placarbil MR Prototype Tablet Formulations
Part 3
- To determine the relative bioavailability of the selected Arbaclofen Placarbil MR Prototype Tablet in the presence of either beverage or food and/or
- To evaluate the PK profile (dose proportionality) of AP and R-baclofen following dosing of the selected Arbaclofen Placarbil MR Prototype A + B Tablet at different dose levels in healthy subjects
- To provide additional information on the safety and tolerability of single doses of AP
Read the detailed description
For Parts 1, 2 and 3, participants will attend the clinical unit for a screening visit up to 28 days before dosing. For each treatment period, eligible subjects will be admitted to the clinical unit on the evening before dosing (Day -1). Participants will receive each regimen in the morning of Day 1 and will remain on site until 48 h post-dose. There will be a minimum washout period of 7 days between administration of each regimen. Where interim decisions occur, the interval between periods will be sufficient to permit the decision process.
Arbaclofen Placarbil MR Prototype Tablets will be administered in Part 1 and one prototype will be selected for development in Part 2 where the release rate of modified release (MR) prototype formulations will be optimised using a design space concept (at a fixed low dose).
A selected MR prototype formulation from Part 2 may be administered in Part 3 at up to 4 different dose levels (low, mid-low, mid-high, high). The suggested doses in Part 3 may be modified based on emerging safety and PK data from Part 2 of the study.
In Parts 2 and 3, there will be an option to dose selected Arbaclofen Placarbil MR Prototype Tablets in the fed state.
- Conditions
- Healthy Volunteers
- Being tested
- Arbaclofen Placarbil SR, Arbaclofen Placarbil MR Prototype A, Arbaclofen Placarbil MR Prototype B, Arbaclofen Placarbil IR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbaclofen Placarbil SRDrug
One low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state.
Arbaclofen Placarbil MR Prototype ADrug
One low dose oral tablet pf Arbaclofen Placarbil modified release (MR) Prototype A in the fasted state; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
Arbaclofen Placarbil MR Prototype BDrug
One low dose oral tablet of Arbaclofen Placarbil modified release (MR) Prototype B; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
Arbaclofen Placarbil IRDrug
One low dose oral capsule of Arbaclofen Placarbil immediate release (IR) in the fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Regimen A | Experimental | One low dose Arbaclofen Placarbil MR Prototype A tablet taken under fasting conditions.
Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A |
| Part 1: Regimen B | Experimental | One low dose Arbaclofen Placarbil MR Prototype B tablet taken under fasting conditions.
Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype B |
| Part 1: Regimen C | Active comparator | One low dose Arbaclofen Placarbil SR tablet taken under fasting conditions as the reference product.
Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. Receives: Drug: Arbaclofen Placarbil SR |
| Part 1: Regimen D | Experimental | One low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice.
Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 1: Regimen E | Experimental | An optional regimen of one low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice.
Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 2: Regimen F | Experimental | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions.
Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 2: Regimen G | Active comparator | One low dose Arbaclofen Placarbil IR capsule taken under fasting conditions as the reference product.
Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. Receives: Drug: Arbaclofen Placarbil IR |
| Part 2: Regimen H | Experimental | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions.
Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 2: Regimen I | Experimental | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions.
Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 2: Regimen J | Experimental | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions, or a previously dosed MR prototype in the fed state. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 3: Regimen K | Experimental | One low dose selected Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 2) taken under fasting conditions.
Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 3: Regimen L | Experimental | One low dose selected Arbaclofen Placarbil MR prototype tablet administered with 0.6 g/kg of beverage in orange juice or in the fed state, or one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet.
Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 3: Regimen M | Experimental | An optional regimen of one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen L) or one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet taken under fasting conditions.
Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
| Part 3: Regimen N | Experimental | An optional regimen of one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen M) or two mid-low dose of the selected Arbaclofen Placarbil MR prototype tablets.
Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. Receives: Drug: Arbaclofen Placarbil MR Prototype A; Drug: Arbaclofen Placarbil MR Prototype B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Time to Maximum Concentration (Tmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Secondary outcomes (75)
Part 1: Maximum Observed Concentration (Cmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Concentrations at 12 Hours Post-dose (C12) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose at 12 hours
Part 1: Concentrations at 24 Hours Post-dose (C24) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose at 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 12 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen AUC Ratios in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen Cmax Ratios in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Slope of the Apparent Elimination Phase (lambda-z) in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Elimination Half-life (T1/2) in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Relative Bioavailability of AP and R-baclofen following administration of Arbaclofen Placarbil Modified Release (MR) Prototypes A + B Compared to Reference Arbaclofen Placarbil Sustained Release (SR)
The relative bioavailability of AP and R-baclofen following administration of arbaclofen placarbil modified release (MR) prototypes A + B compared to reference AP sustained release (SR), by calculation of Frel (relative bioavailability).
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Time to Maximum Concentration (Tmax) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Maximum Observed Concentration (Cmax) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Concentrations at 12 Hours Post-dose (C12) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose at 12 hours
Part 1: Concentrations at 24 Hours Post-dose (C24) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose at 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 12 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen AUC Ratios in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen Cmax Ratios in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Slope of the Apparent Elimination Phase (lambda-z) in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Elimination Half-life (T1/2) in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected MR prototype formulation(s) in the presence of beverage compared to when dosed with water only.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Relative Bioavailability of AP and R-baclofen Following Administration of Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Relative Bioavailability of AP and R-baclofen following administration of selected MR prototype formulation(s) when taken with beverage compared to taken with water, calculated by Frel.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Time to Maximum Concentration (Tmax) of AP and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low-dose MR prototype formulation(s).
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Maximum Observed Concentration (Cmax) of Arbaclofen Placarbil (AP) and R-baclofen in in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Concentrations at 12 Hours Post-dose (C12) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose at 12 hours
Part 2: Concentrations at 24 Hours Post-dose (C24) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s) Prototypes A + B
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose at 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 12 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen AUC Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen Cmax Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Slope of the Apparent Elimination Phase (lambda-z) in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Apparent Elimination Half-life (T1/2) in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototypes.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Relative Bioavailability of AP and R-baclofen following administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototypes Compared to Reference Arbaclofen Placarbil Immediate Release (IR)
The relative bioavailability of AP and R-baclofen following administration of selected arbaclofen placarbil modified release (MR) Prototypes A + B compared to reference AP immediate release (IR), by calculation of Frel (relative bioavailability).
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Relative Bioavailability of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
The relative bioavailability of AP and R-baclofen following administration of Arbaclofen Placarbil Modified Release (MR) Prototype in a fed state compared to a fasted state, by calculation of Frel (relative bioavailability).
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Time to Maximum Concentration (Tmax) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Maximum Observed Concentration (Cmax) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Concentrations at 12 Hours Post-dose (C12) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose at 12 hours
Part 2: Concentrations at 24 Hours Post-dose (C24) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose at 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 12 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of AP and R-baclofen Following Administration of Selected Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen AUC Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
The relative bioavailability of AP and R-baclofen following administration of Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen Cmax Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Slope of the Apparent Elimination Phase (lambda-z) in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Apparent Elimination Half-life (T1/2) in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype in Both a Fed and Fasted State
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in selected low dose arbaclofen placarbil modified release (MR) prototype administered in a fed state compared to a fasted state.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Relative Bioavailability of AP and R-baclofen in a Selected MR Prototype Formulation in the Fed State Compared to Fasted State
An optional outcome dependent upon decision-making in response to interim PK observations. This outcome reports the relative bioavailability of AP and R-baclofen in a selected MR prototype formulation in the fed state compared to fasted, by calculation of Frel. An alternative is to compare the bioavailability of AP and R-baclofen when taken with beverage compared to taken with water, calculated by Frel.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Time to Maximum Concentration (Tmax) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Maximum Observed Concentration (Cmax) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Concentrations at 12 Hours Post-dose (C12) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose at 12 hours
Part 3: Concentrations at 24 Hours Post-dose (C24) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose at 24 hours
Part 3: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 12 hours
Part 3: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 24 hours
Part 3: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of AP and R-baclofen in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: AP:R-baclofen AUC Ratios in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: AP:R-baclofen Cmax Ratios in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: The Slope of the Apparent Elimination Phase (lambda-z) in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: The Apparent Elimination Half-life (T1/2) in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Part 3: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in a Selected MR Prototype Formulation at Different Dose Levels
An optional outcome dependent upon decision-making in response to interim PK observations. Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in a selected MR prototype formulation at different dose levels.
Measured: Day 1 (pre-dose), post-dose up to 48 hours
Parts 1, 2 and 3: Participants with Adverse Events
The number of participants in categories of treatment-emergent adverse events.
Measured: Days 1-2 of each regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start24 Jan 2017
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The Clinical Trial Authorisation application for this study describes a flexible protocol design using the formulation design space concept to allow decision-making in response to interim PK observations
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Director, Clinical Development, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058237
- Sponsor's protocol ID
- INDV-AP-102
- Other IDs
- 2016-003792-22, 2016
- Status last verified
- Jan 2018
- First submitted
- 9 Feb 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03058237
- Acronym / sponsor ID
- INDV-AP-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part 1
- To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects
- To determine the relative bioavailability of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype A Tablet and Arbaclofen Placarbil MR Prototype B Tablet compared to the reference Arbaclofen Placarbil Sustained Release (SR) Tablets (low dose)
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of the selected MR prototype formulation(s) in the presence of beverage
- To provide additional information on the safety and tolerability of single doses of AP
Part 2
- To evaluate the PK profile of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype Tablets in healthy subjects
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of Arbaclofen Placarbil MR Prototype Tablets compared to the reference Arbaclofen Placarbil Immediate Release (IR) Capsule
- To provide additional information on the safety and tolerability of single doses of AP
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing of a selected MR prototype formulation in the fed state (optional)
- To explore a possible in vitro in vivo correlation/relationship (IVIVC/IVIVR) for the Arbaclofen Placarbil MR Prototype Tablet Formulations
Part 3
- To determine the relative bioavailability of the selected Arbaclofen Placarbil MR Prototype Tablet in the presence of either beverage or food and/or
- To evaluate the PK profile (dose proportionality) of AP and R-baclofen following dosing of the selected Arbaclofen Placarbil MR Prototype A + B Tablet at different dose levels in healthy subjects
- To provide additional information on the safety and tolerability of single doses of AP
Detailed description
For Parts 1, 2 and 3, participants will attend the clinical unit for a screening visit up to 28 days before dosing. For each treatment period, eligible subjects will be admitted to the clinical unit on the evening before dosing (Day -1). Participants will receive each regimen in the morning of Day 1 and will remain on site until 48 h post-dose. There will be a minimum washout period of 7 days between administration of each regimen. Where interim decisions occur, the interval between periods will be sufficient to permit the decision process.
Arbaclofen Placarbil MR Prototype Tablets will be administered in Part 1 and one prototype will be selected for development in Part 2 where the release rate of modified release (MR) prototype formulations will be optimised using a design space concept (at a fixed low dose).
A selected MR prototype formulation from Part 2 may be administered in Part 3 at up to 4 different dose levels (low, mid-low, mid-high, high). The suggested doses in Part 3 may be modified based on emerging safety and PK data from Part 2 of the study.
In Parts 2 and 3, there will be an option to dose selected Arbaclofen Placarbil MR Prototype Tablets in the fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 14
- Model description
- The Clinical Trial Authorisation application for this study describes a flexible protocol design using the formulation design space concept to allow decision-making in response to interim PK observations
| Arm | Type | Receives |
|---|---|---|
| Part 1: Regimen A | Experimental | Drug: Arbaclofen Placarbil MR Prototype AOne low dose Arbaclofen Placarbil MR Prototype A tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen B | Experimental | Drug: Arbaclofen Placarbil MR Prototype BOne low dose Arbaclofen Placarbil MR Prototype B tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen C | Active comparator | Drug: Arbaclofen Placarbil SROne low dose Arbaclofen Placarbil SR tablet taken under fasting conditions as the reference product. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen D | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen E | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BAn optional regimen of one low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 2: Regimen F | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen G | Active comparator | Drug: Arbaclofen Placarbil IROne low dose Arbaclofen Placarbil IR capsule taken under fasting conditions as the reference product. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen H | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen I | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen J | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions, or a previously dosed MR prototype in the fed state. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 3: Regimen K | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose selected Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 2) taken under fasting conditions. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen L | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BOne low dose selected Arbaclofen Placarbil MR prototype tablet administered with 0.6 g/kg of beverage in orange juice or in the fed state, or one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen M | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BAn optional regimen of one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen L) or one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet taken under fasting conditions. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen N | Experimental | Drug: Arbaclofen Placarbil MR Prototype A, Drug: Arbaclofen Placarbil MR Prototype BAn optional regimen of one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen M) or two mid-low dose of the selected Arbaclofen Placarbil MR prototype tablets. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males
- Non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 30.0 kg/m^2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent prior to any study-specific procedures
Key exclusion criteria (22 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any clinically significant drug/substance or alcohol abuse or disorders in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbaclofen Placarbil SROne low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state. | Drug | Part 1: Regimen C |
| Arbaclofen Placarbil MR Prototype AOne low dose oral tablet pf Arbaclofen Placarbil modified release (MR) Prototype A in the fasted state; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice | Drug | Part 1: Regimen A, Part 1: Regimen D, Part 1: Regimen E, Part 2: Regimen F, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M, Part 3: Regimen N |
| Arbaclofen Placarbil MR Prototype BOne low dose oral tablet of Arbaclofen Placarbil modified release (MR) Prototype B; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice | Drug | Part 1: Regimen B, Part 1: Regimen D, Part 1: Regimen E, Part 2: Regimen F, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M, Part 3: Regimen N |
| Arbaclofen Placarbil IROne low dose oral capsule of Arbaclofen Placarbil immediate release (IR) in the fasted state. | Drug | Part 2: Regimen G |
Primary outcome
Part 1: Time to Maximum Concentration (Tmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
75 secondary outcomes
Part 1: Maximum Observed Concentration (Cmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Concentrations at 12 Hours Post-dose (C12) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose at 12 hours
Part 1: Concentrations at 24 Hours Post-dose (C24) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose at 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 12 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen AUC Ratios in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen Cmax Ratios in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Slope of the Apparent Elimination Phase (lambda-z) in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Elimination Half-life (T1/2) in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Relative Bioavailability of AP and R-baclofen following administration of Arbaclofen Placarbil Modified Release (MR) Prototypes A + B Compared to Reference Arbaclofen Placarbil Sustained Release (SR)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Time to Maximum Concentration (Tmax) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Maximum Observed Concentration (Cmax) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Concentrations at 12 Hours Post-dose (C12) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose at 12 hours
Part 1: Concentrations at 24 Hours Post-dose (C24) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose at 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 12 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 24 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of AP and R-baclofen in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen AUC Ratios in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: AP:R-baclofen Cmax Ratios in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Slope of the Apparent Elimination Phase (lambda-z) in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Elimination Half-life (T1/2) in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: The Apparent Volume of Plasma Cleared of AP and R-baclofen per Unit Time Following Extravascular Dosing in Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 1: Relative Bioavailability of AP and R-baclofen Following Administration of Selected MR Prototype Formulation(s) When Taken with Beverage Compared to Taken With Water
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Time to Maximum Concentration (Tmax) of AP and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Maximum Observed Concentration (Cmax) of Arbaclofen Placarbil (AP) and R-baclofen in in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Concentrations at 12 Hours Post-dose (C12) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose at 12 hours
Part 2: Concentrations at 24 Hours Post-dose (C24) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s) Prototypes A + B
Time frame: Day 1 (pre-dose), post-dose at 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 12 Hours post-dose (AUC(0-12)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 12 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to 24 Hours post-dose (AUC(0-24)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 24 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 to Last Measurable Concentration (AUC(0-last)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Area under the Concentration vs Time Curve From Time 0 Extrapolated to Infinity (AUC(0-inf)) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: Percentage of AUC(0-inf) Extrapolated Beyond Last Measured Time Point (AUC%extrap) of Arbaclofen Placarbil (AP) and R-baclofen in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen AUC Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Part 2: AP:R-baclofen Cmax Ratios in Selected Low Dose Arbaclofen Placarbil Modified Release (MR) Prototype(s)
Time frame: Day 1 (pre-dose), post-dose up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Director, Clinical Development study director
Indivior Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arbaclofen Placarbil SR, Arbaclofen Placarbil MR Prototype A and Arbaclofen Placarbil MR Prototype B in people with Healthy Volunteers, run by Indivior Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Time to Maximum Concentration (Tmax) of Arbaclofen Placarbil (AP) and R-baclofen in Low Dose Arbaclofen Placarbil Modified Release (MR) Prototypes A + B (time frame: Day 1 (pre-dose), post-dose up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.