A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986278 suspension; Drug: BMS-986278 Tablet; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON (LPRA) - Salt Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
• Women and men must agree to follow specific methods of contraception

Exclusion Criteria:

• Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding
• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
• Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
• History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment A: BMS-986278 suspension, fasted	Drug: BMS-986278 suspension; Specified dose on specified days
EXPERIMENTAL: Treatment B: BMS-986278 tablet, fasted	Drug: BMS-986278 Tablet; Specified dose on specified days
EXPERIMENTAL: Treatment C: BMS-986278 tablet, fed	Drug: BMS-986278 Tablet; Specified dose on specified days
EXPERIMENTAL: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted	Drug: BMS-986278 Tablet; Specified dose on specified days; Drug: Esomeprazole; Specified dose on specified days; Other Names: NEXIUM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of BMS-986278	Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278	Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 29 days
Incidence of Serious Adverse (SAE's)	Up to 57 days
Incidence of AEs leading to discontinuation	Up to 29 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 48 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 48 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 48 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 48 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 48 days
Incidence of clinically significant changes in physical examination findings	Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests	Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 48 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2020
• Primary Completion (ACTUAL): October 7, 2020
• Study Completion (ACTUAL): October 7, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: IM027-054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No