A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: BMS-986196

Study type: Interventional

Funder types: Industry

Identifiers

NCT06034899

IM038-1014

Details and patient eligibility

About

The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight ≥ 50 kg.
• Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).

Exclusion criteria

• Any significant acute or chronic medical illness in the assessment of the investigator.
• Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
• Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).

Note: 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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0 participants in 4 patient groups

Part 1: BMS-986196 Dose 1 (Treatment A)

Experimental group

Treatment:

Drug: BMS-986196

Part 1: BMS-986196 Dose 1 (Treatment B)

Experimental group

Treatment:

Drug: BMS-986196

Part 2: BMS-986196 Dose 2 (Treatment A)

Experimental group

Treatment:

Drug: BMS-986196

Part 2: BMS-986196 Dose 2 (Treatment B)

Experimental group

Treatment:

Drug: BMS-986196