Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT04039373
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
- Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, with no current use of tobacco
- A negative QuantiFERON-TB Gold® test result at screening or documentation of a negative result within 3 months of the screening visit and a weight ≥ 50 kg and BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
- Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study.
- Men who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with BMS-986256 or MMF, plus 5 half-lives of BMS-986256 (19 days) plus an additional 90 days (duration of sperm turnover) for a total of 109 days post treatment. In addition, participants must be willing to refrain from sperm donation during this time.
Exclusion Criteria
- Any significant acute or chronic medical illness or condition, in the opinion of the investigator in addition to prior exposure to BMS-986256
- Major surgery within 4 weeks before study treatment administration, drug abuse or drug addiction.
- Participants who have smoked or used smoking cessation or other nicotine-containing products within 6 months before the first dose of study drug.
- History or presence of malignancy including hematological malignancies. However,participants with a history of basal cell or squamous cell carcinoma of the skin that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm BMS-986256 - Treatment Arm Mycophenolate Mofetil -
- Primary Outcome Measures
Name Time Method Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax) days 1-5 and days 26 -30 mycophenolic acid (MPA) PK parameter: area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC (0-T) Days 1-5 and Days 26 -30 Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF) Days 1-5 and days 26 -30
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) up to 51 days Vital signs of body temperature up to 51 days Vital signs of respiratory rate up to 51 days Incidence of Serious Adverse Events (SAEs) up to 51 days Number of Clinically significant changes in lab assessment of blood serum up to 51 days Number of Clinically significant changes in lab assessment of urine up to 51 days Number of Clinically significant changes in assessment of blood up to 51 days Vital signs of blood pressure up to 51 days Number of Participants with abnormal physical examination findings up to 51 days
Trial Locations
- Locations (1)
PRA Health Sciences - Salt Lake
🇺🇸Salt Lake City, Utah, United States