A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Famotidine; Drug: BMS-986256

Study type: Interventional

Funder types: Industry

Identifiers

NCT04941755

IM026-029

Details and patient eligibility

About

The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants, defined as having no clinically significant deviations from normal in medical history
• Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
• Normal renal function at screening

Exclusion criteria

• Any significant acute or chronic medical illness
• Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
• Any major surgery within 4 weeks of study treatment administration
• Significant history of GI abnormalities

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Sequence AB

Experimental group

Treatment:

Drug: BMS-986256

Drug: Famotidine

Sequence BA

Experimental group

Treatment:

Drug: BMS-986256

Drug: Famotidine