An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986278; Drug: Rifampin

• Registration Number: NCT03712540
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-06
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Primary Completion: 2018-11-08
• Study Completion: 2018-11-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986278 + Rifampin	Rifampin	Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
BMS-986278 + Rifampin	BMS-986278	Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) for BMS-986278	Day 1 and 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278	Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278	Up to 24 days
Terminal phase half-life (T-HALF) for BMS-986278	Day 1 and 8

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAE)	Up to 24 days
Incidence of AE leading to discontinuation	Up to 24 days
Incidence of non-serious adverse events (AE)	Up to 24 days
Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests	Up to 24 days
Maximum observed plasma concentration (Cmax) for Rifampin	Day 8
Time of maximum observed plasma concentration (Tmax) for Rifampin	Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin	Day 8-9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin	Day 8-9

Trial Locations

Locations (1)

PRA Health Science KK; 🇺🇸 Lenexa, Kansas, United States