Clinical trial NCT03712540: An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
Official title: A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* History of significant cardiovascular disease
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) for BMS-986278
timeFrame: Day 1 and 8
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
timeFrame: Up to 24 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
timeFrame: Day 1 and 8
measure: Terminal phase half-life (T-HALF) for BMS-986278
timeFrame: Day 1 and 8
Secondary outcomes:
measure: Incidence of non-serious adverse events (AE)
timeFrame: Up to 24 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 24 days
measure: Incidence of AE leading to discontinuation
timeFrame: Up to 24 days
measure: Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests
timeFrame: Up to 24 days
measure: Maximum observed plasma concentration (Cmax) for Rifampin
timeFrame: Day 8
measure: Time of maximum observed plasma concentration (Tmax) for Rifampin
timeFrame: Day 8
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin
timeFrame: Day 8-9
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin
timeFrame: Day 8-9
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Science KK
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: