A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Bristol-Myers Squibb1 site in 1 country16 target enrollmentMay 8, 2019

ConditionsHealthy

InterventionsBMS-986205 omeprazole

DrugsBMS-986205 omeprazole

Overview

Phase: Phase 1
Intervention: BMS-986205
Conditions: Healthy
Sponsor: Bristol-Myers Squibb
Enrollment: 16
Locations: 1
Primary Endpoint: Maximum Observed Plasma Concentration (Cmax) of BMS-986205
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.

Registry

clinicaltrials.gov

Start Date

May 8, 2019

End Date

July 20, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (\>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2)
•Body mass index (BMI) of 18.0 kilogram per meter square (kg/m\^2) to 32.0 kg/m\^2
•Women participants must have documented proof that they are not of childbearing potential

Exclusion Criteria

•Women who are of childbearing potential or breastfeeding
•Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
•Concomitant use of strong inhibitors or strong inducers of CYP3A4
•Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Arms & Interventions

BMS-986205 + Omeprazole

Intervention: BMS-986205

BMS-986205 + Omeprazole

Intervention: omeprazole

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of BMS-986205

Time Frame: Up to Day 29

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205

Time Frame: Up to Day 29

Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

Time Frame: Up to Day 29

Secondary Outcomes

Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation(Up to Day 36)
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities(Up to Day 29)
Number of Participants with Physical Examination Abnormalities(Up to Day 29)
Number of Participants with Vital Sign Abnormalities(Up to Day 29)
Number of Participants with Clinical Laboratory Results Abnormalities(Up to Day 29)