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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712540
• Other study ID #: IM027-017
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2018
• Est. completion date: November 8, 2018

Study information

• Verified date: June 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 8, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986278
Oral administration 30 mg
• Rifampin
Oral administration 600 mg

Locations

Country	Name	City	State
United States	PRA Health Science KK	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for BMS-986278		Day 1 and 8
Primary	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
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278		Day 1 and 8
Primary	Terminal phase half-life (T-HALF) for BMS-986278		Day 1 and 8
Secondary	Incidence of non-serious adverse events (AE)		Up to 24 days
Secondary	Incidence of serious adverse events (SAE)		Up to 24 days
Secondary	Incidence of AE leading to discontinuation		Up to 24 days
Secondary	Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests		Up to 24 days
Secondary	Maximum observed plasma concentration (Cmax) for Rifampin		Day 8
Secondary	Time of maximum observed plasma concentration (Tmax) for Rifampin		Day 8
Secondary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin		Day 8-9
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin		Day 8-9

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form