Healthy VolunteersPhase 1NCT02413255
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
A Phase 1 study testing TAK-020 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants. 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?
- TAK-020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2015to 4 May 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant eligibility is determined according to the following criteria prior to entry into the study:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- Participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Participant is a healthy adult male or female.
- The participant is a health adult male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- The participant weighs at least 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use adequate contraception from signing of informed consent throughout the duration of the study and until the next menstrual period or 30 days after last dose, whichever is first. If the next menstrual period is delayed, a pregnancy test will be required for exclusion of pregnancy.
Who cannot join
- Any participant who meets any of the following criteria will not qualify for entry into the study:
- The participant has received any investigational compound within 30 days prior to Screening.
- The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Participant has a known hypersensitivity to any component of the formulation of TAK-020, Captisol or related compounds.
- The participant has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic beverages per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
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- Participant has taken any excluded medication, supplements, or food products, Prohibited Medications and Dietary Products.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 1 month after exit from this study (30 days post last dose); or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
- Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-020, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
- Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [example, cholecystectomy]).
- Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
- Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
- The participant has poor peripheral venous access.
- Participant has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
- Vaccination with any live vaccine within 4 weeks of study drug administration.
- Participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator medically qualified sub investigator.
- Participant has QT interval with Fridericia correction method (QTcF) greater than (>) 450 millisecond (msec) for men and women or PR outside the range of 120 to 220 msec confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).
- Participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2* the upper limit of normal (ULN).
- Positive screen test for drugs of abuse.
- Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus-1 or -2 antibodies.
- A positive test for tuberculosis (TB) (QuantiFERON).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-020 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
Read the detailed description
The drug being tested in this study is called TAK-020. TAK-020 is being tested to evaluate safety and tolerability of single doses and 7 days multiple doses of TAK-020 in healthy volunteers. This study will look at the PK characteristics (how the drug acts throughout the body) of the drug and safety and tolerability (lab results, vital signs, ECG, and side effects) in healthy participants who take TAK-020.
The study will enroll a total of approximately 120 participants. This study is designed to consist of 2 sequential parts: Part 1-a SRD, and Part 2-a MRD. Healthy participants for Part 1 will be enrolled into 9 cohorts. Each cohort will have 8 randomized participants with receiving a single dose of TAK-020, and 2 receiving matching placebo under fasted conditions. In Cohorts 1-9 doses of 0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70 and 105 mg will be evaluated.
Healthy participants for Part 2 will be enrolled into 7 cohorts. Each cohort will have 8 randomized participants, with participants receiving one dose of TAK-020 on Day 1, followed by a washout on Day 2, then daily dosing on Days 3-9 of TAK-020 with 2 participants receiving matching placebo under fasted conditions. In Cohorts 1-4 doses of 3.75, 5.75, 13 and 25 mg will be evaluated. For Cohorts 5-7, the subsequent dose level is to be determined based on data from Part 1 and review of safety, tolerability and PK data from Part 2 Cohorts 1-4.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 45 days. Participants in Part 1 will make multiple visits to the clinic including a period of confinement to the clinic and will be contacted by telephone 14 days after the last dose of study drug for a follow-up assessment. Participants in Part 2 will make multiple visits to the clinic including a period of confinement to the clinic and will be observed at the clinic 17 days after the last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-020, TAK-020 Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-020Drug
TAK-020 oral solution
TAK-020 PlaceboDrug
TAK-020 placebo-matching oral solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Placebo comparator | TAK-020 placebo-matching solution, orally, once on Day 1. Receives: Drug: TAK-020 Placebo |
| Part 1 Cohort 1: TAK-020 0.1 mg | Experimental | TAK-020 0.1 mg, solution, orally once on Day 1. Receives: Drug: TAK-020 |
| Part 1 Cohort 2: TAK-020 0.5 mg | Experimental | TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1. Receives: Drug: TAK-020 |
| Part 1 Cohort 3: TAK-020 2.5 mg | Experimental | TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2. Receives: Drug: TAK-020 |
| Part 1 Cohort 4: TAK-020 4.4 mg | Experimental | TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3. Receives: Drug: TAK-020 |
| Part 1 Cohort 5: TAK-020 8.8 mg | Experimental | TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4. Receives: Drug: TAK-020 |
| Part 1 Cohort 6: TAK-020 17.5 mg | Experimental | TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5. Receives: Drug: TAK-020 |
| Part 1 Cohort 7: TAK-020 35 mg | Experimental | TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 6. Receives: Drug: TAK-020 |
| Part 1 Cohort 8: TAK-020 70 mg | Experimental | TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 7. Receives: Drug: TAK-020 |
| Part 1 Cohort 9: TAK-020 105 mg | Experimental | TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 8. Receives: Drug: TAK-020 |
| Part 2 Cohort 1-6: Placebo | Placebo comparator | TAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9. Receives: Drug: TAK-020 Placebo |
| Part 2 Cohort 1: TAK-020 3.75 mg | Experimental | TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study. Receives: Drug: TAK-020 |
| Part 2 Cohort 2: TAK-020 5.75 mg | Experimental | TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2. Receives: Drug: TAK-020 |
| Part 2 Cohort 3: TAK-020 13 mg | Experimental | TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2. Receives: Drug: TAK-020 |
| Part 2 Cohort 4: TAK-020 25 mg | Experimental | TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2. Receives: Drug: TAK-020 |
| Part 2 Cohort 5: TAK-020 45 mg | Experimental | TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2. Receives: Drug: TAK-020 |
| Part 2 Cohort 6: TAK-020 60 mg | Experimental | TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2. Receives: Drug: TAK-020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Measured: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD)
Safety laboratory tests includes hematology, serum chemistries, and urinalysis.
Measured: From Day 1 to Day 14 of Part 1
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD)
Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).
Measured: From Day 1 to Day 14 of Part 1
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD)
A standard 12-lead ECG was performed. Change from baseline=CFB.
Measured: From Day 1 to Day 14 in Part 1
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Measured: First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD)
Safety laboratory tests include hematology, and serum chemistries.
Measured: From Day 1 to Day 17 in Part 2
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD)
Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).
Measured: From Day 1 to Day 17 in Part 2
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD)
A standard 12-lead ECG was performed.
Measured: From Day 1 to Day 17 in Part 2
Secondary outcomes (35)
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2
Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD)
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD)
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD)
Measured: From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD)
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD)
CL/F was calculated as dose/AUC∞.
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD)
CL/F was calculated as dose/AUCτ.
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Vz/F was calculated as (CL/F)/λz.
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Vz/F was calculated as (CL/F)/λz.
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD)
Ae(0-24) was calculated as calculated as Cur*Vur, where Cur was the concentration of drug excreted in urine and Vur is the volume of urine excreted.
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD)
Ae(0-24) is calculated as calculated as Cur*Vur, where Cu was the concentration of drug excreted in urine and Vur is the volume of urine excreted.
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD)
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Fe was calculated as (Aet/dose)*100.
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD)
Fe was calculated as (Aet/dose)*100.
Measured: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Fe was calculated as (Aet/dose)*100.
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Renal Clearance (CLr) for TAK-020 in Part 1 (SRD)
CLr was calculated as (Ae96/AUCt)*100.
Measured: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Renal Clearance (CLr) for TAK-020 in Part 2 (MRD)
CLr was calculated as (Ae24/AUC24)*100.
Measured: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD)
Measured: Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start18 Mar 2015
- Primary completion4 May 2017
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413255
- Sponsor's protocol ID
- TAK-020-1001
- Other IDs
- U1111-1163-9637
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2015
- Last updated
- 7 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-020 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02413255
- Acronym / sponsor ID
- TAK-020-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 7 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
Detailed description
The drug being tested in this study is called TAK-020. TAK-020 is being tested to evaluate safety and tolerability of single doses and 7 days multiple doses of TAK-020 in healthy volunteers. This study will look at the PK characteristics (how the drug acts throughout the body) of the drug and safety and tolerability (lab results, vital signs, ECG, and side effects) in healthy participants who take TAK-020.
The study will enroll a total of approximately 120 participants. This study is designed to consist of 2 sequential parts: Part 1-a SRD, and Part 2-a MRD. Healthy participants for Part 1 will be enrolled into 9 cohorts. Each cohort will have 8 randomized participants with receiving a single dose of TAK-020, and 2 receiving matching placebo under fasted conditions. In Cohorts 1-9 doses of 0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70 and 105 mg will be evaluated.
Healthy participants for Part 2 will be enrolled into 7 cohorts. Each cohort will have 8 randomized participants, with participants receiving one dose of TAK-020 on Day 1, followed by a washout on Day 2, then daily dosing on Days 3-9 of TAK-020 with 2 participants receiving matching placebo under fasted conditions. In Cohorts 1-4 doses of 3.75, 5.75, 13 and 25 mg will be evaluated. For Cohorts 5-7, the subsequent dose level is to be determined based on data from Part 1 and review of safety, tolerability and PK data from Part 2 Cohorts 1-4.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 45 days. Participants in Part 1 will make multiple visits to the clinic including a period of confinement to the clinic and will be contacted by telephone 14 days after the last dose of study drug for a follow-up assessment. Participants in Part 2 will make multiple visits to the clinic including a period of confinement to the clinic and will be observed at the clinic 17 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1-9: Placebo | Placebo comparator | Drug: TAK-020 PlaceboTAK-020 placebo-matching solution, orally, once on Day 1. |
| Part 1 Cohort 1: TAK-020 0.1 mg | Experimental | Drug: TAK-020TAK-020 0.1 mg, solution, orally once on Day 1. |
| Part 1 Cohort 2: TAK-020 0.5 mg | Experimental | Drug: TAK-020TAK-020 0.5 mg, solution, orally, once on Day 1 following review of safety, tolerability and pharmacokinetic (PK) data from Cohort 1. |
| Part 1 Cohort 3: TAK-020 2.5 mg | Experimental | Drug: TAK-020TAK-020 2.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 2. |
| Part 1 Cohort 4: TAK-020 4.4 mg | Experimental | Drug: TAK-020TAK-020 4.4 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 3. |
| Part 1 Cohort 5: TAK-020 8.8 mg | Experimental | Drug: TAK-020TAK-020 8.8 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 4. |
| Part 1 Cohort 6: TAK-020 17.5 mg | Experimental | Drug: TAK-020TAK-020 17.5 mg, solution, orally once on Day 1 following review of safety, tolerability and PK data from Cohort 5. |
| Part 1 Cohort 7: TAK-020 35 mg | Experimental | Drug: TAK-020TAK-020 35 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 6. |
| Part 1 Cohort 8: TAK-020 70 mg | Experimental | Drug: TAK-020TAK-020 70 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 7. |
| Part 1 Cohort 9: TAK-020 105 mg | Experimental | Drug: TAK-020TAK-020 105 mg, solution, orally once on Day 1. TAK-020 dose will be determined based on review of safety, tolerability and PK data from Cohort 8. |
| Part 2 Cohort 1-6: Placebo | Placebo comparator | Drug: TAK-020 PlaceboTAK-020 placebo-matching solution, orally, once on Day 1 and Days 3 to 9. |
| Part 2 Cohort 1: TAK-020 3.75 mg | Experimental | Drug: TAK-020TAK-020 3.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose are determined based on data from Part 1 of the study. |
| Part 2 Cohort 2: TAK-020 5.75 mg | Experimental | Drug: TAK-020TAK-020 5.75 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 1 in Part 2. |
| Part 2 Cohort 3: TAK-020 13 mg | Experimental | Drug: TAK-020TAK-020 13 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 2 in Part 2. |
| Part 2 Cohort 4: TAK-020 25 mg | Experimental | Drug: TAK-020TAK-020 25 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose will be determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 3 in Part 2. |
| Part 2 Cohort 5: TAK-020 45 mg | Experimental | Drug: TAK-020TAK-020 45 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 4 in Part 2. |
| Part 2 Cohort 6: TAK-020 60 mg | Experimental | Drug: TAK-020TAK-020 60 mg, solution, orally once on Day 1 and Days 3-9. TAK-020 dose was determined based on data from Part 1 and review of safety, tolerability and PK data from Cohort 5 in Part 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant eligibility is determined according to the following criteria prior to entry into the study:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- Participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Participant is a healthy adult male or female.
- The participant is a health adult male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Key exclusion criteria (23 listed)
- Any participant who meets any of the following criteria will not qualify for entry into the study:
- The participant has received any investigational compound within 30 days prior to Screening.
- The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Participant has a known hypersensitivity to any component of the formulation of TAK-020, Captisol or related compounds.
- The participant has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
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 |
|---|---|---|
| TAK-020TAK-020 oral solution | Drug | Part 1 Cohort 1: TAK-020 0.1 mg, Part 1 Cohort 2: TAK-020 0.5 mg, Part 1 Cohort 3: TAK-020 2.5 mg, Part 1 Cohort 4: TAK-020 4.4 mg, Part 1 Cohort 5: TAK-020 8.8 mg, Part 1 Cohort 6: TAK-020 17.5 mg, Part 1 Cohort 7: TAK-020 35 mg, Part 1 Cohort 8: TAK-020 70 mg, Part 1 Cohort 9: TAK-020 105 mg, Part 2 Cohort 1: TAK-020 3.75 mg, Part 2 Cohort 2: TAK-020 5.75 mg, Part 2 Cohort 3: TAK-020 13 mg, Part 2 Cohort 4: TAK-020 25 mg, Part 2 Cohort 5: TAK-020 45 mg, Part 2 Cohort 6: TAK-020 60 mg |
| TAK-020 PlaceboTAK-020 placebo-matching oral solution | Drug | Part 1 Cohort 1-9: Placebo, Part 2 Cohort 1-6: Placebo |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD)
Time frame: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD)
Time frame: From Day 1 to Day 14 of Part 1
Safety laboratory tests includes hematology, serum chemistries, and urinalysis.
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD)
Time frame: From Day 1 to Day 14 of Part 1
Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).
Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD)
Time frame: From Day 1 to Day 14 in Part 1
A standard 12-lead ECG was performed. Change from baseline=CFB.
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD)
Time frame: First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD)
Time frame: From Day 1 to Day 17 in Part 2
Safety laboratory tests include hematology, and serum chemistries.
Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD)
Time frame: From Day 1 to Day 17 in Part 2
Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).
Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD)
Time frame: From Day 1 to Day 17 in Part 2
A standard 12-lead ECG was performed.
35 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2
Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD)
Time frame: From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1
Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2
Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Renal Clearance (CLr) for TAK-020 in Part 1 (SRD)
Time frame: Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1
Renal Clearance (CLr) for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD)
Time frame: Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
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 TAK-020 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
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 8 inclusion and 23 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 7 Jan 2019. 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 States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD) (time frame: First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1). The study lists 8 primary outcomes in all. 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 7 Jan 2019.