Clinical trial NCT06034899: A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Keywords: BMS-986196
Healthy adult participants
Pharmacokinetics
Cross-over study
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Predose and post-dose up to Day 10
measure: Maximum observed serum concentration (Cmax)
timeFrame: Predose and post-dose up to Day 10
measure: Time of Cmax (Tmax)
timeFrame: Predose and post-dose up to Day 10
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Day 36
measure: Number of participants with serious AEs (SAEs)
timeFrame: Up to Day 36
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 11
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 11
measure: Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11
timeFrame: Baseline, Day 11
measure: Number of participants with physical examination findings
timeFrame: Up to Day 11
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 11
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: