Healthy Participants Clinical Trial
Official title:
A Phase 1, 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Itraconazole, Food, and pH, on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants
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.
| Status | Recruiting |
| Enrollment | 32 |
| Est. completion date | June 8, 2024 |
| Est. primary completion date | June 8, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Celerion | Tempe | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 11 days | ||
| Primary | 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 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 11 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 41 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 17 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 17 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 17 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 17 days | ||
| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 17 days |
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