Clinical trial NCT04039373: Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants


Eligibility criteria: 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.

Primary outcomes:
measure: Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)
timeFrame: days 1-5 and days 26 -30
measure: 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)
timeFrame: Days 1-5 and Days 26 -30
measure: Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF)
timeFrame: Days 1-5 and days 26 -30
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: up to 51 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: up to 51 days
measure: Number of Clinically significant changes in lab assessment of blood serum
timeFrame: up to 51 days
measure: Number of Clinically significant changes in assessment of blood
timeFrame: up to 51 days
measure: Number of Clinically significant changes in lab assessment of urine
timeFrame: up to 51 days
measure: Vital signs of blood pressure
timeFrame: up to 51 days
measure: Vital signs of body temperature
timeFrame: up to 51 days
measure: Vital signs of respiratory rate
timeFrame: up to 51 days
measure: Number of Participants with abnormal physical examination findings
timeFrame: up to 51 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: