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OpenTrials
Completed

NCT Number: NCT03979248

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Netherlands

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days.

rabeprazole

Drug

Specified dose on specified days.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986165

    Time frame: Day 1 and Day 9

  2. Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165

    Time frame: Day 1 and Day 9

  3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165

    Time frame: Day 1 and Day 9

Secondary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Day 12

  2. Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)

    Time frame: Up to Day 12

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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