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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03979248
Enrollment
21
Registered
2019-06-07
Start date
2019-05-16
Completion date
2019-07-07
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBMS-986165

Specified dose on specified days.

DRUGRabeprazole

Specified dose on specified days.

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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/

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026