A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-986205
* Drug: omeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986205 + Omeprazole<br> | Drug: BMS-986205<br>* Participants will receive BMS-986205 on Days 1 and 15<br>Drug: omeprazole<br>* Participants will receive omeprazole on Days 10 to 15<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of BMS-986205 |  | 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 |  | Up to Day 29 | 
| Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] |  | Up to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation |  | Up to Day 36 | 
| Number of Participants with Vital Sign Abnormalities |  | Up to Day 29 | 
| 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 Clinical Laboratory Results Abnormalities |  | Up to Day 29 |