An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2018
Shorter than P25 for phase_1
1 active site
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
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedAugust 29, 2018
August 1, 2018
2 months
June 11, 2018
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) of BMS-986224
5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
5 days
Secondary Outcomes (10)
Biomarker plasma concentrations of BMS-986224
5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224
5 days
Terminal elimination half-life (T-HALF) of BMS-986224
5 days
Metabolite of BMS-986224 Cmax
5 days
Metabolite of BMS-986224 AUC(0-T)
5 days
- +5 more secondary outcomes
Study Arms (1)
Rifampin + BMS-986224
EXPERIMENTALOral administration
Interventions
Eligibility Criteria
You may qualify if:
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening
You may not qualify if:
- Women of childbearing potential
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Salt Lake City, Utah, 84107, 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
June 11, 2018
First Posted
June 20, 2018
Study Start
June 1, 2018
Primary Completion
July 27, 2018
Study Completion
July 27, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08