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

NCT05760937 | Completed Phase 1 FDA Drug

• 1 other identifier: IM054-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics; Pharmacodynamics; Healthy Participants; BMS-986447

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events (AEs)

  Up to 59 days

• Number of Participants with Serious AEs (SAEs)

  Up to 59 days

• Number of Participants with Clinical Laboratory Abnormalities

  Up to 34 days

• Number of Participants with Vital Sign Abnormalities

  Up to 35 days

• Number of Participants with Physical Examination Abnormalities

  Up to 35 days

• Number of Participants with Electrocardiogram (ECG) Abnormalities

  Up to 34 days

Secondary Outcomes (3)

• 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

Study Arms (2)

BMS-986447

EXPERIMENTAL

Drug: BMS-986447

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-986447 DRUG

Specified dose on specified days

BMS-986447

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: March 10, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)