A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

NCT06170723 — Phase 1, Completed, 32 participants, Celgene

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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

Registry	NCT06170723
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	32 (Actual)
Sponsor	Celgene (Industry)
Conditions	Healthy Participants
Interventions	BMS-986368, Itraconazole, Famotidine (Drug)
Dates	start 2024-03-18, primary completion 2024-05-25, completion 2024-05-25, first posted 2023-12-14, last updated 2024-07-01
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions
Part 1: BMS-986368 - Fasted	Experimental	Drug: BMS-986368
Part 1: Itraconazole - Fasted	Experimental	Drug: Itraconazole
Part 1: BMS-986368 with Itraconazole - Fasted	Experimental	Drug: BMS-986368; Drug: Itraconazole
Part 2: BMS-986368 - Fasted	Experimental	Drug: BMS-986368
Part 2: BMS-986368 - Fed	Experimental	Drug: BMS-986368
Part 2: Famotidine, followed by BMS-986368 - Fasted	Experimental	Drug: BMS-986368; Drug: Famotidine

BMS-986368 (Drug): Specified dose on specified days
Itraconazole (Drug): Specified dose on specified days
Famotidine (Drug): Specified dose on specified days

+Outcome measures

Primary outcomes

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 outcomes

Number of participants with adverse events (AEs) [Up to 41 days]
Number of participants with physical examination abnormalities [Up to 17 days]
Number of participants with vital sign abnormalities [Up to 17 days]
Number of participants with electrocardiogram (ECG) abnormalities [Up to 17 days]
Number of participants with clinical laboratory abnormalities [Up to 17 days]
Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to 17 days]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Local Institution - 0001	Tempe, Arizona	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb