An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
- Registration Number
- NCT03660436
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 131
Inclusion Criteria
- Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2
Exclusion Criteria
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Positive anti- John Cunningham virus (JCV) antibody test at Screening
- History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986165 + MMF BMS-986165 Oral administration BMS-986165 + MMF MMF Oral administration
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of mycophenolic acid (MPA) 18 days Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA 18 days AUC extrapolated to infinity (AUC[INF]) of MPA 18 days
- Secondary Outcome Measures
Name Time Method Number of adverse events (AE) Up to 48 days Number of serious adverse events (SAE) Up to 48 days Number of AEs leading to discontinuation Up to 48 days Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results 18 days
Trial Locations
- Locations (1)
PRA Health Sciences
🇺🇸Salt Lake City, Utah, United States