A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS-986435

• Registration Number: NCT07226817
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-07
• Study First Submitted QC: 2025-11-07
• Last Update Submitted: 2025-11-07
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2025-11-12
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	BMS-986435	-
Treatment B	BMS-986435	-
Treatment C	BMS-986435	-
Treatment D	BMS-986435	-
Treatment E	BMS-986435	-
Treatment F	BMS-986435	-
Treatment G	BMS-986435	-

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to Day 28

Secondary Outcome Measures

Name	Time	Method
Time of maximum observed concentration (Tmax)	Up to Day 28
Half-life (T-HALF)	Up to Day 28
Apparent total body clearance (CLT/F)	Up to Day 28
Volume of distribution of terminal phase (Vz/F)	Up to Day 28
Number of participants with Adverse Events (AEs)	Up to Day 35
Number of participants with Serious AEs (SAEs)	Up to Day 35
Number of participants with clinical laboratory abnormalities	Up to Day 28
Number of participants with vital sign abnormalities	Up to Day 28
Number of participants with physical examination abnormalities	Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 28

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Miami, Florida, United States