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
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2019
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2019
CompletedFirst Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2019
CompletedNovember 2, 2020
October 1, 2020
2 months
June 6, 2019
October 30, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax) of BMS-986165
Day 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-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
Secondary Outcomes (2)
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
Study Arms (1)
BMS-986165 + Rabeprazole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences - Netherlands
Groningen, 9728 NZ, Netherlands
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 7, 2019
Study Start
May 16, 2019
Primary Completion
July 7, 2019
Study Completion
July 7, 2019
Last Updated
November 2, 2020
Record last verified: 2020-10