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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03563950
Enrollment
42
Registered
2018-06-20
Start date
2018-06-01
Completion date
2018-07-27
Last updated
2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief 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.

Interventions

DRUGRifampin

Specified dose on specified days

DRUGBMS-986224

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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/

Design outcomes

Primary

MeasureTime frame
Maximum observed plasma concentration (Cmax) of BMS-9862245 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-9862245 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-9862245 days

Secondary

MeasureTime frame
Metabolite of BMS-986224 Cmax5 days
Metabolite of BMS-986224 AUC(0-T)5 days
Metabolite of BMS-986224 AUC(INF)5 days
Biomarker plasma concentrations of BMS-9862245 days
Incidence of serious adverse events (SAE)30 days
Incidence of AEs leading to discontinuation17 days
Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests18 days
Incidence of nonserious adverse events (AE)17 days
Time of maximum observed plasma concentration (Tmax) of BMS-9862245 days
Terminal elimination half-life (T-HALF) of BMS-9862245 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026