A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT06170723
- Lead Sponsor
- Celgene
- Brief Summary
This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) to 33.0 kg/m^2, inclusive.
Exclusion Criteria
- Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
- Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: BMS-986368 - Fasted BMS-986368 - Part 1: BMS-986368 with Itraconazole - Fasted Itraconazole - Part 2: BMS-986368 - Fasted BMS-986368 - Part 2: BMS-986368 - Fed BMS-986368 - Part 2: Famotidine, followed by BMS-986368 - Fasted BMS-986368 - Part 2: Famotidine, followed by BMS-986368 - Fasted Famotidine - Part 1: BMS-986368 with Itraconazole - Fasted BMS-986368 - Part 1: Itraconazole - Fasted Itraconazole -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 11 days Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) Up to 11 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 11 days
- Secondary Outcome Measures
Name Time Method Number of participants with vital sign abnormalities Up to 17 days Number of participants with adverse events (AEs) Up to 41 days Number of participants with electrocardiogram (ECG) abnormalities Up to 17 days Columbia-Suicide Severity Rating Scale (C-SSRS) Up to 17 days Number of participants with physical examination abnormalities Up to 17 days Number of participants with clinical laboratory abnormalities Up to 17 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Tempe, Arizona, United States