Healthy SubjectsPhase 1NCT03464058
Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
A Phase 1 study testing BOS172767 tablets, BOS172767 liquid capsules and BOS172767 micronized capsules in people with Healthy Subjects, run by Boston Pharmaceuticals at 1 site in United Kingdom.
Trial summary
Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- BOS172767 tablets, BOS172767 liquid capsules and BOS172767 micronized capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2018to 10 Oct 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 50 years of age at time of signing informed consent
- Body mass index of 18.0 to 32.0 kilograms per meters squared (kg/m^2) at Screening, 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 have a negative Quantiferon tuberculosis test at Screening
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Who cannot join
- Participants who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months prior to dosing
- Participants who are study site employees, or immediate family members of a study site or sponsor employee
- Participants who have previously been enrolled (dosed) in this study
- History of any drug or alcohol abuse in the past 2 years prior to Screening
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliters [mL] of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months prior to Screening. A breath carbon monoxide reading of greater than 20 parts per million at Screening or admission
Show all 21Show fewer
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to Screening
- Females of childbearing potential
- Participants 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
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
- Evidence of renal impairment at Screening, as indicated by an estimated creatinine clearance of <70 mL/minute using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (including gall stones and/or cholecystectomy), neurological or psychiatric disorder, as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the IMP formulation excipients
- Adverse reaction to rabeprazole, its excipients or any proton pump inhibitors (Part 2 only)
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol or hormone replacement therapy) 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 Principal Investigator and sponsor's medical monitor.
- Participants who have any ongoing fungal infections (stable toe nail onychomycosis is allowed)
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, PPI Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in healthy participants compared to an immediate release capsule formulation (reference), and also to determine the relative bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states.
Part 2 of the study will be conducted to provide additional information on the safety and tolerability of escalating single doses of the selected formulation of BOS172767 in healthy participants, to evaluate the PK profile following increased single doses of the selected formulation of BOS172767 following administration in healthy participants, and also to evaluate the dose linearity of the selected prototype.
Part 3 of the study will be conducted to provide additional information on the safety, tolerability, and PK of the selected formulation of BOS172767 following multiple ascending doses (MADs) over 14 days of dosing in healthy participants.
Read the detailed description
Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12 healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover with an optional fourth dosing period in 10 healthy participants. Participants will be dosed on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36 healthy participants (12 per study cohort). Participants will be dosed on 3 separate occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Parts 2 and 3 are contingent upon successful completion of Part 1.
- Conditions
- Healthy Subjects
- Being tested
- BOS172767 tablets, BOS172767 liquid capsules, BOS172767 micronized capsules, BOS172767 immediate release capsules, BOS172767 matching placebo capsules
- Keywords
- Pharmacokinetics, Food Effect, Proton Pump Inhibitors, Drug Interaction, Oral Prototype Formulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOS172767 tabletsDrug
Oral tablets
BOS172767 liquid capsulesDrug
Oral capsules
BOS172767 micronized capsulesDrug
Oral capsules
BOS172767 immediate release capsulesDrug
Oral capsules
BOS172767 matching placebo capsulesDrug
Oral capsules
BOS172767 matching placebo tabletsDrug
Oral tablets
RabeprazoleDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Regimen A | Experimental | Participants will be treated with a BOS172767 200 milligram (mg) spray dried dispersion tablet (2 × 100 mg tablets) in the fasted state on Day 1. Receives: Drug: BOS172767 tablets |
| Part 1: Regimen B | Experimental | Participants will be treated with a BOS172767 200 mg lipid capsule (2 × 100 mg capsules) in the fasted state on Day 1. Receives: Drug: BOS172767 liquid capsules |
| Part 1: Regimen C | Experimental | Participants will be treated with a BOS172767 200 mg micronized capsule (2 × 100 mg capsules) in the fasted state on Day 1. Receives: Drug: BOS172767 micronized capsules |
| Part 1: Regimen D | Experimental | Participants will be treated with a BOS172767 200 mg immediate release reference capsule formulation (2 × 100 mg capsules) in the fasted state on Day 1. Receives: Drug: BOS172767 immediate release capsules |
| Part 1: Regimen E | Experimental | Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules |
| Part 1: Regimen F | Experimental | Participants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules |
| Part 2: Regimen G | Experimental | Participants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules |
| Part 2: Regimen H | Experimental | Participants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules |
| Part 2: Regimen I | Experimental | Participants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules |
| Part 2: Regimen J | Experimental | Participants will be treated with rabeprazole on Days -3 to -1, and a selected dose of the BOS172767 prototype in the fasted state on Day 1. Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules; Drug: Rabeprazole |
| Part 3: Regimen K | Experimental | Participants will be treated with 400 mg of a BOS172767 prototype or matching placebo once daily (QD) or twice daily (BID) for 14 days (Days 1 to 14). Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules; Drug: BOS172767 matching placebo capsules; Drug: BOS172767 matching placebo tablets |
| Part 3: Regimen L | Experimental | Participants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14). Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules; Drug: BOS172767 matching placebo capsules; Drug: BOS172767 matching placebo tablets |
| Part 3: Regimen M | Experimental | Participants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14). Receives: Drug: BOS172767 tablets; Drug: BOS172767 liquid capsules; Drug: BOS172767 micronized capsules; Drug: BOS172767 immediate release capsules; Drug: BOS172767 matching placebo capsules; Drug: BOS172767 matching placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)
Measured: up to 33 weeks
Parts 1, 2, and 3: Number of participants with any treatment-emergent non-serious adverse event (TEAE)
Measured: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings
Measured: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings
Measured: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values
Measured: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings
Measured: up to 33 weeks
Parts 1 and 2: Plasma concentration of BOS172722
Measured: predose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 hours postdose (Day 1); 24 and 36 hours postdose (Day 2); 48 hours postdose (Day 3)
Part 2 (Regimen I): Plasma concentration of BOS172722
Measured: admission to pre-dose (admission to dosing), 0 to 6 (Day 1), 6 to 12 (Day 1), 12 to 24 (Day 1), and 24 to 48 (Days 2 to 3) hours postdose
Part 3: Plasma concentration of BOS172722
Measured: Days 1 and 7: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose. Days 4, 6, 9, 11, and 12: pre-dose. Day 14: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-final dose
Part 3 (Regimen M): Plasma concentration of BOS172722
Measured: admission to pre-dose on Day 1; 0 to 6, 6 to 12, and 12 to 24 hours postdose on Days 1, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start21 Mar 2018
- Primary completion9 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464058
- Sponsor's protocol ID
- BOS172767-01
- Other IDs
- 2017-004002-18, QCL118174, 2017
- Status last verified
- Nov 2020
- First submitted
- 7 Mar 2018
- Last updated
- 18 Nov 2020
- Results posted
- No
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, PPI Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03464058
- Acronym / sponsor ID
- BOS172767-01
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Food Effect, Proton Pump Inhibitors, Drug Interaction, Oral Prototype Formulations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boston PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 13 Mar 2018 (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 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in healthy participants compared to an immediate release capsule formulation (reference), and also to determine the relative bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states.
Part 2 of the study will be conducted to provide additional information on the safety and tolerability of escalating single doses of the selected formulation of BOS172767 in healthy participants, to evaluate the PK profile following increased single doses of the selected formulation of BOS172767 following administration in healthy participants, and also to evaluate the dose linearity of the selected prototype.
Part 3 of the study will be conducted to provide additional information on the safety, tolerability, and PK of the selected formulation of BOS172767 following multiple ascending doses (MADs) over 14 days of dosing in healthy participants.
Detailed description
Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12 healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover with an optional fourth dosing period in 10 healthy participants. Participants will be dosed on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36 healthy participants (12 per study cohort). Participants will be dosed on 3 separate occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each treatment period.
Parts 2 and 3 are contingent upon successful completion of Part 1.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1: Regimen A | Experimental | Drug: BOS172767 tabletsParticipants will be treated with a BOS172767 200 milligram (mg) spray dried dispersion tablet (2 × 100 mg tablets) in the fasted state on Day 1. |
| Part 1: Regimen B | Experimental | Drug: BOS172767 liquid capsulesParticipants will be treated with a BOS172767 200 mg lipid capsule (2 × 100 mg capsules) in the fasted state on Day 1. |
| Part 1: Regimen C | Experimental | Drug: BOS172767 micronized capsulesParticipants will be treated with a BOS172767 200 mg micronized capsule (2 × 100 mg capsules) in the fasted state on Day 1. |
| Part 1: Regimen D | Experimental | Drug: BOS172767 immediate release capsulesParticipants will be treated with a BOS172767 200 mg immediate release reference capsule formulation (2 × 100 mg capsules) in the fasted state on Day 1. |
| Part 1: Regimen E | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsulesParticipants will be treated with a selected dose of a prototype formulation of BOS172767 in the fasted state on Day 1. |
| Part 1: Regimen F | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsulesParticipants will be treated with a selected dose of a prototype formulation of BOS172767 in the fed state on Day 1. |
| Part 2: Regimen G | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsulesParticipants will be treated with 400 mg of the selected BOS172767 prototype in the fasted state on Day 1. |
| Part 2: Regimen H | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsulesParticipants will be treated with 600 mg of the selected BOS172767 prototype in the fasted state on Day 1. |
| Part 2: Regimen I | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsulesParticipants will be treated with 800 mg of the selected BOS172767 prototype in the fasted state on Day 1. |
| Part 2: Regimen J | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsules, Drug: RabeprazoleParticipants will be treated with rabeprazole on Days -3 to -1, and a selected dose of the BOS172767 prototype in the fasted state on Day 1. |
| Part 3: Regimen K | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsules, Drug: BOS172767 matching placebo capsules, Drug: BOS172767 matching placebo tabletsParticipants will be treated with 400 mg of a BOS172767 prototype or matching placebo once daily (QD) or twice daily (BID) for 14 days (Days 1 to 14). |
| Part 3: Regimen L | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsules, Drug: BOS172767 matching placebo capsules, Drug: BOS172767 matching placebo tabletsParticipants will be treated with 600 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14). |
| Part 3: Regimen M | Experimental | Drug: BOS172767 tablets, Drug: BOS172767 liquid capsules, Drug: BOS172767 micronized capsules, Drug: BOS172767 immediate release capsules, Drug: BOS172767 matching placebo capsules, Drug: BOS172767 matching placebo tabletsParticipants will be treated with 800 mg of a BOS172767 prototype or matching placebo QD or BID for 14 days (Days 1 to 14). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males or healthy females of non-child bearing potential
- Age 18 to 50 years of age at time of signing informed consent
- Body mass index of 18.0 to 32.0 kilograms per meters squared (kg/m^2) at Screening, 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 have a negative Quantiferon tuberculosis test at Screening
Key exclusion criteria (21 listed)
- Participants who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months prior to dosing
- Participants who are study site employees, or immediate family members of a study site or sponsor employee
- Participants who have previously been enrolled (dosed) in this study
- History of any drug or alcohol abuse in the past 2 years prior to Screening
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliters [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 |
|---|---|---|
| BOS172767 tabletsOral tablets | Drug | Part 1: Regimen A, Part 1: Regimen E, Part 1: Regimen F, Part 2: Regimen G, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| BOS172767 liquid capsulesOral capsules | Drug | Part 1: Regimen B, Part 1: Regimen E, Part 1: Regimen F, Part 2: Regimen G, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| BOS172767 micronized capsulesOral capsules | Drug | Part 1: Regimen C, Part 1: Regimen E, Part 1: Regimen F, Part 2: Regimen G, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| BOS172767 immediate release capsulesOral capsules | Drug | Part 1: Regimen D, Part 1: Regimen E, Part 1: Regimen F, Part 2: Regimen G, Part 2: Regimen H, Part 2: Regimen I, Part 2: Regimen J, Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| BOS172767 matching placebo capsulesOral capsules | Drug | Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| BOS172767 matching placebo tabletsOral tablets | Drug | Part 3: Regimen K, Part 3: Regimen L, Part 3: Regimen M |
| RabeprazoleOral tablets | Drug | Part 2: Regimen J |
Primary outcome
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE)
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with any treatment-emergent non-serious adverse event (TEAE)
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant physical examination findings
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant safety laboratory test findings
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant vital sign values
Time frame: up to 33 weeks
Parts 1, 2, and 3: Number of participants with abnormal, clinically significant electrocardiogram findings
Time frame: up to 33 weeks
Parts 1 and 2: Plasma concentration of BOS172722
Time frame: predose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 hours postdose (Day 1); 24 and 36 hours postdose (Day 2); 48 hours postdose (Day 3)
Part 2 (Regimen I): Plasma concentration of BOS172722
Time frame: admission to pre-dose (admission to dosing), 0 to 6 (Day 1), 6 to 12 (Day 1), 12 to 24 (Day 1), and 24 to 48 (Days 2 to 3) hours postdose
Part 3: Plasma concentration of BOS172722
Time frame: Days 1 and 7: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose. Days 4, 6, 9, 11, and 12: pre-dose. Day 14: pre-dose; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-final dose
Part 3 (Regimen M): Plasma concentration of BOS172722
Time frame: admission to pre-dose on Day 1; 0 to 6, 6 to 12, and 12 to 24 hours postdose on Days 1, 7, and 14
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 18 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BOS172767 tablets, BOS172767 liquid capsules and BOS172767 micronized capsules in people with Healthy Subjects, run by Boston Pharmaceuticals 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 7 inclusion and 21 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 18 Nov 2020. 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?
Parts 1, 2, and 3: Number of participants with any treatment-emergent serious adverse event (TESAE) (time frame: up to 33 weeks). The study lists 10 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 18 Nov 2020.