A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986419 IR Tablet; Drug: BMS-986419 DR Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05963932

CN007-1001

Details and patient eligibility

About

The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male 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 evaluations.
• Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and body weight ≥ 50 kg.
• A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)

Exclusion criteria

• Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
• History of Gilbert's syndrome.
• Women who are of childbearing potential and women who are breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Treatment A: BMS-986419 DR Capsule - Fasted

Experimental group

Treatment:

Drug: BMS-986419 DR Capsule

Treatment B: BMS-986419 IR Tablet - Fasted

Experimental group

Treatment:

Drug: BMS-986419 IR Tablet

Treatment C: BMS-986419 IR Tablet - Fed

Experimental group

Treatment:

Drug: BMS-986419 IR Tablet

Treatment D: BMS-986419 Crushed IR Tablet - Fed

Experimental group

Treatment:

Drug: BMS-986419 IR Tablet