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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05760937
• Collaborator: (none)
• Enrollment: 32
• Arms: 2
• Anticipated Duration (Months): 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986447; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants
• Anticipated Study Start Date: Mar 10, 2023
• Anticipated Primary Completion Date: Aug 26, 2023
• Anticipated Study Completion Date: Aug 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986447	Drug: BMS-986447; Specified dose on specified days
Placebo Comparator: Placebo	Drug: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events (AEs) [Up to 59 days]

2. Number of Participants with Serious AEs (SAEs) [Up to 59 days]

3. Number of Participants with Clinical Laboratory Abnormalities [Up to 34 days]

4. Number of Participants with Vital Sign Abnormalities [Up to 35 days]

5. Number of Participants with Physical Examination Abnormalities [Up to 35 days]

6. Number of Participants with Electrocardiogram (ECG) Abnormalities [Up to 34 days]

Secondary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 72 hours postdose]

2. Time of maximum observed plasma concentration (Tmax) [Up to 72 hours postdose]

3. Apparent terminal phase half-life (T-Half) [Up to 72 hours postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05760937
• Other Study ID Numbers: IM054-003
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Pharmacokinetics; Pharmacodynamics; Healthy Participants; BMS-986447

Study Results

No Results Posted as of Mar 9, 2023