Assess the Effect of Famotidine on the Pharmacokinetics of Afimetoran (QSC300376)
Research type
Research Study
Full title
A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
IRAS ID
1007296
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Research summary
The Sponsor is developing the test medicine, afimetoran, for the potential treatment of systemic lupus erythematosus (SLE), which is the most common form of Lupus. Lupus is a long-term autoimmune disease which occurs when the the body's natural defence system (immune system) attacks healthy parts of the body.
This two-part healthy volunteer study will try to identify whether an approved acid-reducing drug called famotidine, which affects the acidity of the stomach, will affect how the test medicine is taken up by the body and also how it functions within the body.
This study will take place at one non-NHS site, enrolling up to 76 male and female volunteers aged between 18-55. Different volunteers will be enrolled in Part 1 and Part 2.
In Part 1, up to 32 volunteers will be split into 2 cohorts. Each cohort will receive 1 of 2 afimetoran tablet recipes in the fasted state on 2 separate occasions. On 1 occasion it will be given with famotidine and on the other it will be given without; there will be a break of at least 19 days between dosing.
Part 2 is optional. Up to 44 volunteers will be split into 2 cohorts. Each cohort will receive 1 of 2 afimetoran capsule recipes on 1 occasion, either with or without famotidine, in the fasted state.
In each part volunteers will be discharged 5 days after dosing. In Part 1 volunteers will have return visits on Days 10 and 16 in both periods, and also Day 20 in Period 2. In Part 2 volunteers will have a return visit on Day 10. All volunteers will return for a follow-up visit 23 to 27 days post final dose.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 11 weeks from screening to the follow up visit in Part 1, and approximately 8 weeks in Part 2.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0137
Date of REC Opinion
28 Jun 2023
REC opinion
Further Information Favourable Opinion