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Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2020
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2020
CompletedMarch 31, 2022
March 1, 2022
7 days
March 6, 2020
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Maximum plasma concentration (Cmax) of BMS-986235
Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
Day 1
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
Day 1
Cmax of BMS-986235 with rifampin
Day 10
AUC(0-T) of BMS-986235 with rifampin
Day 10
AUC(INF) of BMS-986235 with rifampin
Day 10
Secondary Outcomes (12)
Incidence of Nonserious Adverse Events (AEs)
Up to 46 days
Incidence of Serious Adverse Events (SAEs)
Up to 74 days
Incidence of AEs leading to discontinuation
Up to 13 days
Incidence of clinically significant changes from baseline in physical examination findings
Up to 41 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 41 days
- +7 more secondary outcomes
Study Arms (1)
Treatment Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
- Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
- Males must agree to follow specific methods of contraception, if applicable
You may not qualify if:
- Women of childbearing potential (WOCBP)
- Known previous exposure to BMS-986235
- History of any significant drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 10, 2020
Study Start
March 9, 2020
Primary Completion
March 16, 2020
Study Completion
March 16, 2020
Last Updated
March 31, 2022
Record last verified: 2022-03