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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03979248
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BMS-986165; Drug: Rabeprazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 16, 2019
• Actual Primary Completion Date: Jul 7, 2019
• Actual Study Completion Date: Jul 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165 + Rabeprazole	Drug: BMS-986165; Specified dose on specified days.; Drug: Rabeprazole; Specified dose on specified days.

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of BMS-986165 [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 [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 [Day 1 and Day 9]

Secondary Outcome Measures

1. Percentage of Participants with Adverse Events (AEs) [Up to Day 12]

2. Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs) [Up to Day 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Netherlands	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03979248
• Other Study ID Numbers: IM011-090; 2019-001193-28
• First Posted: Jun 7, 2019
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: BMS-986165; Rabeprazole

Study Results

No Results Posted as of Nov 2, 2020