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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

NCT ID: NCT03979248

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2019-07-07

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986165 + Rabeprazole

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days.

Rabeprazole

Intervention Type DRUG

Specified dose on specified days.

Interventions

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BMS-986165

Specified dose on specified days.

Intervention Type DRUG

Rabeprazole

Specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PRA Health Sciences - Netherlands

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2019-001193-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM011-090

Identifier Type: -

Identifier Source: org_study_id