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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986368
* Drug: Itraconazole
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: BMS-986368 - Fasted<br> | Drug: BMS-986368<br>* Specified dose on specified days<br>|
| Experimental: Part 1: Itraconazole - Fasted<br> | Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: Part 1: BMS-986368 with Itraconazole - Fasted<br> | Drug: BMS-986368<br>* Specified dose on specified days<br>Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: Part 2: BMS-986368 - Fasted<br> | Drug: BMS-986368<br>* Specified dose on specified days<br>|
| Experimental: Part 2: BMS-986368 - Fed<br> | Drug: BMS-986368<br>* Specified dose on specified days<br>|
| Experimental: Part 2: Famotidine, followed by BMS-986368 - Fasted<br> | Drug: BMS-986368<br>* Specified dose on specified days<br>Drug: Famotidine<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986368, Itraconazole, Famotidine, Food Effect, Healthy Volunteers