Food Effect on the PK of BMS-955176 Micronized Crystalline Tablet
Research type
Research Study
Full title
An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
IRAS ID
164095
Contact name
Valerie Perpette
Contact email
Sponsor organisation
Bristol-Myers Squibb Research and Development
Eudract number
2014-003577-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 13 days
Research summary
The Sponsor is developing the study drug, BMS-955176, for the potential treatment of Human Immunodeficiency Virus Type-1 (HIV-1).
The study drug will be dosed in up to 3 groups (cohorts) of healthy male and female subjects (12 subjects per group) aged between 18 and 50 years. All groups will be randomised, 4-way-cross-overs, which means subjects will be randomly allocated to receive 4 different tretments of study drug, 1 each study visit. A 7 day wash-out period (a period in which no study drug is given to subjects) will take place between each treatment.
Group 1 will look at how much study drug (given as tablets at a 180 mg dose) is taken up by the body when given after a light meal, a standard meal and after a high fat meal when compared to when it is given in the fasted state (after no meal).
Groups 2 and 3 will only go ahead if the amount of study drug taken up by the body has not met a target amount. Group 2 will look at how much study drug is taken up by the body when given as tablets at a different dose (up to 240 mg) than in Group 1 after a light meal, a standard meal and after a high fat meal, compared to when it is given in the fasted state (after no meal). Group 3 will look at how much study drug is taken up by the body when given as different forms (eg, suspension) at different dose levels after a standard meal.
The safety and tolerability of the study drug will also be assessed.
REC name
Wales REC 1
REC reference
14/WA/1157
Date of REC Opinion
8 Oct 2014
REC opinion
Further Information Favourable Opinion