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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS-986419 DR Capsule; Drug: BMS-986419 IR Tablet

• Registration Number: NCT05963932
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-27
• Study Start: 2023-08-08
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: BMS-986419 DR Capsule - Fasted	BMS-986419 DR Capsule	-
Treatment B: BMS-986419 IR Tablet - Fasted	BMS-986419 IR Tablet	-
Treatment C: BMS-986419 IR Tablet - Fed	BMS-986419 IR Tablet	-
Treatment D: BMS-986419 Crushed IR Tablet - Fed	BMS-986419 IR Tablet	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Up to 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	Up to 15 days

Secondary Outcome Measures

Name	Time	Method
Number of participants with vital sign abnormalities	Up to 29 days
Number of participants with physical examination abnormalities	Up to 29 days
Time to attain maximum observed plasma concentration (Tmax)	Up to 15 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))	Up to 15 days
Number of participants with adverse events (AEs)	Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 29 days
Terminal half-life (T-Half)	Up to 15 days
Number of participants with clinical laboratory abnormalities	Up to 29 days

Trial Locations

Locations (1)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States