Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin

Study Overview
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Brief Summary
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The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

Detailed Description
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IND Number: 79,599/101,943 Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Official Title
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Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC
* Drug: BMS-791325
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests Females must be of non-childbearing potential Exclusion Criteria: Women of childbearing potential Any significant acute or chronic medical condition Inability to tolerate oral medications Inability to be venipunctured and/or tolerate venous access Abnormal liver function tests Current or recent (within 3 months of dosing) gastrointestinal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin<br>Treatment A: Rosuvastatin tablet orally on specified days Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days | Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC<br> <br> Drug: BMS-791325<br> <br> Drug: Rosuvastatin<br> <br> * Other names: Crestor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) of Rosuvastatin |  | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) | 
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin |  | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) | 
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin |  | Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed concentration (Tmax) of Rosuvastatin |  | Days 1 and 15 (predose through 96 hours) | 
| Half life (T-HALF) of Rosuvastatin |  | Days 1 and 15 (predose through 96 hours) | 
| Apparent total body clearance (CLT/F) of Rosuvastatin |  | Days 1 and 15 (predose through 96 hours) | 
| Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 |  | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose | 
| Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 |  | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose | 
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 |  | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose | 
| Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 |  | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose | 
| Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712 |  | Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose | 
| Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation |  | Days 1 through 19 | 
| Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests |  | Days 1 through 19 |