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NCT03979248 Clinical Trial

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

Healthy Clinical Trial

Official title:
An Open-Label, Single-Sequence Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole on the Pharmacokinetics of BMS-986165 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03979248
Other study ID # IM011-090
Secondary ID 2019-001193-28
Status Completed
Phase Phase 1
First received
Last updated
Start date May 16, 2019
Est. completion date July 7, 2019

Study information
Verified date October 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 7, 2019
Est. primary completion date July 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria - Healthy participant, as determined by medical history, physical examination, ECGs, and clinical laboratory determinations - Body mass index of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2 - Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than (>) 80 milliliter per minute per 1.732 meter square (mL/min/1.732 m^2) 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-986165
Specified dose on specified days.
• Rabeprazole
Specified dose on specified days.

Locations
Country Name City State
Netherlands PRA Health Sciences - Netherlands Groningen

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Observed Plasma Concentration (Cmax) of BMS-986165 Day 1 and Day 9
Primary 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
Primary Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165 Day 1 and Day 9
Secondary Percentage of Participants with Adverse Events (AEs) Up to Day 12
Secondary Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs) Up to Day 12
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