NCT06433505

A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BMS-986365	Specified dose on specified days
DRUG	[14C] BMS-986365	Specified dose on specified days.
DRUG	[14C] BMS-986409 + BMS-986410	Specified dose on specified days
DRUG	[14C] BMS-986410 + BMS-986409	Specified dose on specified days

Timeline

• Start date: 2024-05-30
• Primary completion: 2025-02-14
• Completion: 2025-02-28
• First posted: 2024-05-29
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study