A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Study Overview
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Brief Summary
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Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

Detailed Description
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A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

Official Title
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A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants

Conditions
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Malignancies Multiple

Intervention / Treatment
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* Drug: BMS-986205
* Drug: Itraconazole
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 18.0 to 32.0 kg/m2, inclusive Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula Women must not be of childbearing potential (cannot become pregnant) Exclusion Criteria: Any significant acute or chronic medical illness History of glucose-6-phosphodiesterase (G6PD) deficiency Personal or family history of cytochrome b5 reductase deficiency Other protocol defined inclusion / exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhibition (Cohort 1)<br>Single oral dose BMS-986205 | Drug: BMS-986205<br>* BMS-986205<br>|
| Experimental: Inhibition (Cohort 2)<br>Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4 | Drug: BMS-986205<br>* BMS-986205<br>Drug: Itraconazole<br>* Oral solution<br>|
| Experimental: Induction (Cohort 3)<br>Single oral dose BMS-986205 | Drug: BMS-986205<br>* BMS-986205<br>|
| Experimental: Induction (Cohort 4)<br>Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 | Drug: BMS-986205<br>* BMS-986205<br>Drug: Rifampin<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentration | Up to 25 days | 
| AUC from time zero to time of last quantifiable concentration (AUC(0-T)) | Measured by plasma concentration | Up to 25 days | 
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Measured by plasma concentration | Up to 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 25 days | 
| Incidence of Serious Adverse Events (SAEs) | Safety and tolerability as measured by incidence of SAEs | Up to 76 days | 
| Number of participants with electrocardiogram abnormalities |  | Up to 25 days | 
| Number of participants with physical examination findings abnormalities |  | Up to 25 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 25 days |