A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Placebo; Drug: BMS-986447

• Registration Number: NCT05760937
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Study Start: 2023-03-10
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive.
• Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
• A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.

Exclusion Criteria

• Participant has any condition that confounds the ability to interpret data from the study.
• Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
• Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BMS-986447	BMS-986447	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious AEs (SAEs)	Up to 59 days
Number of Participants with Adverse Events (AEs)	Up to 59 days
Number of Participants with Vital Sign Abnormalities	Up to 35 days
Number of Participants with Clinical Laboratory Abnormalities	Up to 34 days
Number of Participants with Physical Examination Abnormalities	Up to 35 days
Number of Participants with Electrocardiogram (ECG) Abnormalities	Up to 34 days

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to 72 hours postdose
Time of maximum observed plasma concentration (Tmax)	Up to 72 hours postdose
Apparent terminal phase half-life (T-Half)	Up to 72 hours postdose

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Anaheim, California, United States