Safety,PK, PD and food effect of BMS-986278 given in SAD and MAD in HV
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
IRAS ID
242818
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-004136-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 14 days
Research summary
BMS-986278 is a novel drug that has been developed as a treatment for idiopathic pulmonary fibrosis (IPF). This study is the first time BMS-986278 has been given to humans. Before this part of the study (Part C), BMS-986278 will have already been given to healthy Caucasian volunteers in single doses (Part A) and multiple doses (Part B). This part of the study (Part C) will see healthy Japanese volunteers randomly assigned to receive either BMS-986278 or placebo orally, once daily, for 14 days. Neither the volunteers nor the clinical staff will know which preparation is being given. The purpose of this study is to look at the safety of BMS-986278, as well as how the body processes the drug and what the drug does to the body.
IPF is a disease characterised by progressive scarring and thickening of lung tissue, leading to respiratory failure. BMS-986278 has been shown in laboratory and animal models to be effective against one of the known causes of IPF, Lysophosphatidic acid (LPA). It has also been shown to be well tolerated with no specific safety concerns.
Up to 24 healthy Japanese male or female subjects, aged 21-65 years will be included. There will be three consecutive groups (cohorts) of up to eight subjects (six active and two placebo). The dose will be increased for the following cohort after a review of all the safety data available from the previous cohort.
Participants will be screened to confirm eligibility prior to admission to the Clinical Research Unit (CRU). Participants will be dosed once daily with BMS-986278 or placebo for 14 days. Treatment will start on Day 1 and they will remain in the CRU for close observation. Participants will be discharged on Day 18. Participants will return for follow-up assessments up to Day 28.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0307
Date of REC Opinion
9 Mar 2018
REC opinion
Favourable Opinion