A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.

Official Title
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An Open-label, Single-Sequence, 2-Treatment Period Study to Investigate the Effects of Cytochrome P450 3A4 Inhibition by Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986256
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the Investigator would compromise the conduct, results, or interpretation of the study findings A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months of the screening visit Weight greater than or equal to (>=) 50 kilogram (kg) and body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2) inclusive at screening Exclusion Criteria: Prior exposure to BMS-986256 Previous investigational drug or placebo exposure within 6 weeks before nonbiologic study drug administration or 12 weeks before biologic study drug administration History or presence of malignancy including hematological malignancies. However, participants with a history of basal cell or squamous cell carcinoma that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator Other protocol defined inclusion/exclusion criteria could 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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986256 +Itraconazole<br> | Drug: BMS-986256<br>* Specified dose on specified days<br>Drug: Itraconazole<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) of BMS-986256 |  | After single dose on Days 1 and 29 | 
| Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256 |  | After single dose on Days 1 and 29 | 
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256 |  | After single dose on Days 1 and 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AEs) |  | From the time of study treatment administration through the final study visit (Up to 55 days) | 
| Percentage of Participants with Serious Adverse Events (SAEs) |  | From the time ICF is signed through 30 days post dose, or the final study visit (Up to 60 days) | 
| Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities |  | From screening to follow-up (Up to 55 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytochrome P450 3A4 Inhibition