A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

NCT06034899 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IM038-1014
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed \[high-fat meal\]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.

Conditions

Healthy Adult Volunteers

Keywords

BMS-986196; Healthy adult participants; Pharmacokinetics; Cross-over study

Outcome Measures

Primary Outcomes (3)

• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

  Predose and post-dose up to Day 10

• Maximum observed serum concentration (Cmax)

  Predose and post-dose up to Day 10

• Time of Cmax (Tmax)

  Predose and post-dose up to Day 10

Secondary Outcomes (7)

• Number of participants with adverse events (AEs)

  Up to Day 36

• Number of participants with serious AEs (SAEs)

  Up to Day 36

• Number of participants with vital sign abnormalities

  Up to Day 11

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 11

• Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11

  Baseline, Day 11

Study Arms (4)

Part 1: BMS-986196 Dose 1 (Treatment A)

EXPERIMENTAL

Drug: BMS-986196

Part 1: BMS-986196 Dose 1 (Treatment B)

EXPERIMENTAL

Drug: BMS-986196

Part 2: BMS-986196 Dose 2 (Treatment A)

EXPERIMENTAL

Drug: BMS-986196

Part 2: BMS-986196 Dose 2 (Treatment B)

EXPERIMENTAL

Drug: BMS-986196

Interventions

BMS-986196 DRUG

Specified dose on specified days

Part 1: BMS-986196 Dose 1 (Treatment A); Part 1: BMS-986196 Dose 1 (Treatment B); Part 2: BMS-986196 Dose 2 (Treatment A); Part 2: BMS-986196 Dose 2 (Treatment B)

Eligibility Criteria

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

You may qualify if:

• Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and body weight ≥ 50 kg.
• Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).

You may not qualify if:

• Any significant acute or chronic medical illness in the assessment of the investigator.
• Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
• Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: September 22, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share