Healthy Participants
Conditions
Keywords
BMS-986368, Itraconazole, Famotidine, Food Effect, Healthy Volunteers
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.
Interventions
DRUGBMS-986368
Specified dose on specified days
DRUGItraconazole
Specified dose on specified days
DRUGFamotidine
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 17 days |
| Number of participants with adverse events (AEs) | Up to 41 days |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 17 days |
| Number of participants with clinical laboratory abnormalities | Up to 17 days |
| Number of participants with physical examination abnormalities | Up to 17 days |
| Number of participants with vital sign abnormalities | Up to 17 days |
Countries
United States
Outcome results
None listed