A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BMS-986165; Drug: Rabeprazole

• Registration Number: NCT03979248
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2019-07-07
• Study Completion: 2019-07-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

• Any major surgery within 4 weeks of study drug administration
• Use of any prescription drugs or over-the-counter acid controllers
• Positive urine screen for drugs of abuse, alcohol, or cotinine
• History of allergy to BMS-986165, rabeprazole, or related compounds

Other protocol inclusion/exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BMS-986165 + Rabeprazole	BMS-986165	-
BMS-986165 + Rabeprazole	Rabeprazole	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165	Day 1 and Day 9
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165	Day 1 and Day 9
Maximum Observed Plasma Concentration (Cmax) of BMS-986165	Day 1 and Day 9

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)	Up to Day 12
Percentage of Participants with Adverse Events (AEs)	Up to Day 12

Trial Locations

Locations (1)

PRA Health Sciences - Netherlands; 🇳🇱 Groningen, Netherlands