Healthy Participants
Conditions
Brief summary
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
Interventions
DRUGBMS-986165
Specified dose on specified days
DRUGMMF
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of adverse events (AE) | Up to 48 days |
| Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results | 18 days |
| Number of serious adverse events (SAE) | Up to 48 days |
| Number of AEs leading to discontinuation | Up to 48 days |
Countries
United States
Outcome results
None listed