A Study to Determine the PK profile of BMS-986165 Tablets QSC201950
Research type
Research Study
Full title
A Study to Determine the Pharmacokinetic Profile of BMS-986165 administered as various solid dispersion tablet formulations in Healthy Subjects
IRAS ID
267084
Contact name
Head of Global Clinical Trials Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-002642-20
Duration of Study in the UK
0 years, 4 months, 9 days
Research summary
The Sponsor is developing the test medicine, BMS-986165, for the potential treatment 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).\n\nThe study will look at how trial formulations (recipes) of the test medicine are absorbed by the body and compare these results against absorption of a reference formulation. There is the option to look at the effect food and/or pH (reducing the acidity of the stomach) has on the test medicine. The study will also look at the safety and tolerability of the different formulations of the test medicine.\nThe study will consist of 6 study periods involving up to 18 healthy male and female volunteers. In each period, volunteers will receive a single dose of a reference formulation or one of up to five prototype formulations. In Periods 5 and/or 6, an already licenced medication that reduces the acidity of the stomach may also be administered with the test medicine.\n\nIn each period, volunteers will remain in clinic until discharge on Day 3 and will attend 2 return visits on Days 4 and 5. There will be a minimum washout of 7 days between each period. A follow-up call will take place 5 to 7 days after the final return visit in Period 6 to ensure the ongoing wellbeing of the subjects.\n
REC name
HSC REC A
REC reference
19/NI/0136
Date of REC Opinion
2 Aug 2019
REC opinion
Further Information Favourable Opinion