A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.

Official Title
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A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CC-92480
* Drug: Rifampin
* Drug: Itraconazole
* Drug: Digoxin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a body mass index between 18 and 33 kg/m2 (inclusive) Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments Exclusion Criteria: Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion Any major surgery within 4 weeks of the first dose administration History of drug abuse within 2 years of the first dose administration 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<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: BMS-986348;Drug: Rifampin<br>* Specified dose on specified days<br>|
| Experimental: Part 2<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: BMS-986348;Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: Part 3<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: BMS-986348;Drug: Digoxin<br>* Specified dose on specified days<br>Drug: Rosuvastatin<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 2 months | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 2 months | 
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) |  | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 3 months | 
| Number of participants with physical examination findings |  | Up to 3 months | 
| Number of participants with vital sign abnormalities |  | Up to 3 months | 
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities |  | Up to 3 months | 
| Number of participants with clinical laboratory abnormalities |  | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CC-92480, Healthy Volunteer, Pharmacokinetic