NCT04039373CompletedPhase 1
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil in Healthy Male Participants
Bristol-Myers Squibb1 site in 1 country15 target enrollmentStarted: July 22, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)
Study Overview
Brief Summary
A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment Arm
Experimental
Intervention: BMS-986256 (Drug)
Treatment Arm
Experimental
Intervention: Mycophenolate Mofetil (Drug)
Outcomes
Primary Outcomes
Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)
Time Frame: 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)
Time Frame: 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)
Time Frame: Days 1-5 and days 26 -30
Secondary Outcomes
- 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)
- Incidence of Adverse Events (AEs)(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)
Investigators
Study Sites (1)
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