Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment Group
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Drug: BMS-986235 (Treatment A)
Specified dose on specified days
Drug: Rifampin (Treatment B)
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 41 days]
- Incidence of clinically significant changes in vital signs: Blood pressure [Up to 41 days]
- Incidence of clinically significant changes in vital signs: Heart rate [Up to 41 days]
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 41 days]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 41 days]
- Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests [Up to 41 days]
- Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) [Up to 41 days]
Eligibility Criteria
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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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.
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Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
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Males must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
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Women of childbearing potential (WOCBP)
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Known previous exposure to BMS-986235
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History of any significant drug allergy
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution | Salt Lake City | Utah | United States | 84124 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV018-023