Study to Evaluate the PK of BMS-986165 Tablets (QSC203891)
Research type
Research Study
Full title
A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects
IRAS ID
285115
Contact name
Head of Global Clinical Trials Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-002776-13
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, BMS-986165, for the potential treatment of of immune mediated diseases such as Crohn’s disease (inflammation of the digestive track) psoriasis (red, flaky patches of the skin) and psoriatic arthritis (inflammation of the joints in people with psoriasis).
The study will look at different formulations of the test medicine and how much of the test medicine enters the bloodstream over time (pharmacokinetics) when dosed daily for multiple days. It will also assess how the pharmacokinetics are effected by food, pH (reducing the acidity of the stomach) and alcohol. It will try to assess the proportion of test medicine that enters the bloodstream (relative bioavailability). The safety and tolerability of the test medicine will be assessed.
The study will consist of three parts involving up to 56 healthy male and female volunteers.
Part A and C both consist of two periods, which follow the same study design. Volunteers will enter the clinical unit on Day -1 (day before dosing). Volunteers will receive doses of different formulations of the test medicine on Days 1 to 7, either once or twice daily. Volunteers will be discharged from the clinical unit on Day 11, there will then be a washout period of a minimum of seven days before volunteers return for period two.Part B will consist of five periods completed in one study visit. Volunteers will enter the clinical unit on Day -1 of period one. Volunteers will receive a dose of the test medicine on Day 1 of each period, followed by a seven-day washout period before the next dose. Each period will assess the test medicine under different conditions: fasted, fed, with another marketed medicine to alter the stomach pH and with alcohol.
There will be a follow-up phone call five-seven days post-final discharge for each Part.
Summary of Results
Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
HSC REC B
REC reference
20/NI/0098
Date of REC Opinion
27 Aug 2020
REC opinion
Further Information Favourable Opinion