An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563950
• Other study ID #: CV016-008
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2018
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2018
• 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 if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Inclusion Criteria:

• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

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

Exclusion Criteria:

• Women of childbearing potential

• Any significant acute or chronic medical illness

• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Rifampin
Specified dose on specified days
• BMS-986224
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

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) of BMS-986224		5 days
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224		5 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224		5 days
Secondary	Biomarker plasma concentrations of BMS-986224		5 days
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-986224		5 days
Secondary	Terminal elimination half-life (T-HALF) of BMS-986224		5 days
Secondary	Metabolite of BMS-986224 Cmax		5 days
Secondary	Metabolite of BMS-986224 AUC(0-T)		5 days
Secondary	Metabolite of BMS-986224 AUC(INF)		5 days
Secondary	Incidence of nonserious adverse events (AE)		17 days
Secondary	Incidence of serious adverse events (SAE)		30 days
Secondary	Incidence of AEs leading to discontinuation		17 days
Secondary	Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests		18 days

External Links

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