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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Esomeprazole; Drug: BMS-986278 suspension; Drug: BMS-986278 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04468815

IM027-054

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Treatment A: BMS-986278 suspension, fasted

Experimental group

Treatment:

Drug: BMS-986278 suspension

Treatment B: BMS-986278 tablet, fasted

Experimental group

Treatment:

Drug: BMS-986278 Tablet

Treatment C: BMS-986278 tablet, fed

Experimental group

Treatment:

Drug: BMS-986278 Tablet

Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted

Experimental group

Treatment:

Drug: BMS-986278 Tablet

Drug: Esomeprazole