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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06034899
Collaborator
(none)
28
Enrollment
4
Arms
2.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants
Anticipated Study Start Date :
Sep 22, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: BMS-986196 Dose 1 (Treatment A)

Drug: BMS-986196
Specified dose on specified days
Experimental: Part 1: BMS-986196 Dose 1 (Treatment B)

Drug: BMS-986196
Specified dose on specified days
Experimental: Part 2: BMS-986196 Dose 2 (Treatment A)

Drug: BMS-986196
Specified dose on specified days
Experimental: Part 2: BMS-986196 Dose 2 (Treatment B)

Drug: BMS-986196
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Maximum observed serum concentration (Cmax) [Predose and post-dose up to Day 10]

  3. Time of Cmax (Tmax) [Predose and post-dose up to Day 10]

Secondary Outcome Measures

  1. Number of participants with adverse events (AEs) [Up to Day 36]

  2. Number of participants with serious AEs (SAEs) [Up to Day 36]

  3. Number of participants with vital sign abnormalities [Up to Day 11]

  4. Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 11]

  5. Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11 [Baseline, Day 11]

  6. Number of participants with physical examination findings [Up to Day 11]

  7. Number of participants with clinical laboratory abnormalities [Up to Day 11]

Eligibility Criteria

Criteria

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

  • 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).

Exclusion Criteria:

  • 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).

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:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT06034899
Other Study ID Numbers:
  • IM038-1014
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Aug 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
BMS-986196
Healthy adult participants
Pharmacokinetics
Cross-over study

Study Results

No Results Posted as of Sep 13, 2023