A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

NCT05350800 | Completed Phase 1 FDA Drug

• 1 other identifier: CA073-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.

Conditions

Healthy Volunteer

Keywords

BMS-986369; Healthy Volunteer; CC-99282

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Day 1

• Time of maximum observed plasma concentration (Tmax)

  Day 1

• Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))

  Up to 336 hours after dose administration

Secondary Outcomes (5)

• Number of participants with Adverse Events (AEs)

  From the date of having consented until 30 days after completion of study treatment

• Number of participants with vital sign abnormalities

  Up to Day 15

• Number of participants with clinical laboratory abnormalities

  Up to Day 15

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 15

• Effect of BMS-986369 on ECG parameters - Part 1

  Up to 72 hours

Study Arms (3)

BMS-986369, Part 1 dose escalation

EXPERIMENTAL

Drug: BMS-986369

BMS-986369 under fasted conditions, Part 2 Food effect

EXPERIMENTAL

Drug: BMS-986369

BMS-986369 under fed conditions, Part 2 Food effect

EXPERIMENTAL

Drug: BMS-986369

Interventions

BMS-986369 DRUG

Specified dose on specified days

BMS-986369 under fasted conditions, Part 2 Food effect; BMS-986369 under fed conditions, Part 2 Food effect; BMS-986369, Part 1 dose escalation

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
• Must have a normal or clinically-acceptable 12-lead ECG at screening
• Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1

You may not qualify if:

• Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
• History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
• History of major surgery within 8 weeks before the first dose administration

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Miami, Florida, 33136, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 28, 2022
• Study Start: September 12, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (1)