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)

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986278 suspension; Drug: BMS-986278 Tablet; Drug: Esomeprazole

• Registration Number: NCT04468815
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study Start: 2020-07-10
• Study First Posted: 2020-07-13
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: BMS-986278 suspension, fasted	BMS-986278 suspension	-
Treatment B: BMS-986278 tablet, fasted	BMS-986278 Tablet	-
Treatment C: BMS-986278 tablet, fed	BMS-986278 Tablet	-
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted	BMS-986278 Tablet	-
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted	Esomeprazole	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 clinical laboratory results: Hematology tests	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

Trial Locations

Locations (1)

ICON (LPRA) - Salt Lake; 🇺🇸 Salt Lake City, Utah, United States