Status:
COMPLETED
A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants
Lead Sponsor:
Celgene
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 gas...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) to 33.0 kg/m\^2, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06170723
Start Date
March 18 2024
End Date
May 25 2024
Last Update
July 1 2024
Active Locations (1)
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1
Local Institution - 0001
Tempe, Arizona, United States, 85283