A Study of Experimental Medication BMS-986278 Given to Healthy Participants
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
2 other identifiers
interventional
112
2 countries
2
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedStudy Start
First participant enrolled
February 7, 2018
CompletedFirst Posted
Study publicly available on registry
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2019
CompletedOctober 1, 2019
September 1, 2019
1.1 years
February 5, 2018
September 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
Up to 30 days
Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
Up to 30 days
Study Arms (2)
Single Ascending Dose
EXPERIMENTALBMS-986278 or placebo
Multiple Ascending Dose
EXPERIMENTALBMS-986278 or placebo
Interventions
Eligibility Criteria
You may qualify if:
- Participants must be in good general health in the opinion of the investigator
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
- Body weight between 55 and 105 kg, inclusive, at screening
- Female participants must have documented proof that they are not of childbearing potential
- Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
You may not qualify if:
- Women who are of childbearing potential or breastfeeding
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- Any major surgery within 6 weeks of study drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Local Institution
Groningen, 9728 NZ, Netherlands
Local Institution
London, SE1 1YR, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 12, 2018
Study Start
February 7, 2018
Primary Completion
March 2, 2019
Study Completion
March 2, 2019
Last Updated
October 1, 2019
Record last verified: 2019-09