Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.

Detailed Description
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IND Number: 100,932/79,599/101,943 Primary Purpose: Other: Phase 1 clinical pharmacology bioavailability study to assess food effect

Official Title
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An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: DCV 3DAA FDC


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 male and female subjects ages 18 to 49 years, inclusive. Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration. Exclusion Criteria: Any significant acute or chronic medical illness Current or recent (within 3 months of study drug administration) gastrointestinal disease Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease Use of tobacco-containing or nicotine-containing products Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat: PR ≥210 msec QRS ≥120 msec QT ≥500 msec QTcF ≥450 msec Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat: Alanine aminotransferase (ALT) >Upper limit of normal (ULN) Aspartate aminotransferase (AST) >ULN Total bilirubin (TBILI) >ULN Creatinine >ULN

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: DCV 3DAA FDC fasted state<br>DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state | Drug: DCV 3DAA FDC<br>* Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325<br>|
| Experimental: Treatment B: DCV 3DAA FDC with high-fat meal<br>DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal | Drug: DCV 3DAA FDC<br>* Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325<br>|
| Experimental: Treatment C: DCV 3DAA FDC with light meal<br>DCV 3DAA FDC tablet by mouth once on specified days with light meal | Drug: DCV 3DAA FDC<br>* Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325<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 DCV, ASV and BMS-791325 |  | Day 1 to Day 13 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325 |  | Day 1 to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325 |  | Day 1 to Day 13 | 
| Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325 |  | Day 1 to Day 13 | 
| Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325 |  | Day 1 to Day 13 | 
| AUC(0-T) for BMS-794712 |  | Day 1 to Day 13 | 
| AUC(INF) for BMS-794712 |  | Day 1 to Day 13 | 
| Cmax for BMS-794712 |  | Day 1 to Day 13 | 
| Tmax for BMS-794712 |  | Day 1 to Day 13 | 
| T-HALF for BMS-794712 |  | Day 1 to Day 13 | 
| Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation |  | Day 1 to Day 13 | 
| Safety measured by abnormalities in vital sign measurements |  | Day 1 to Day 13 | 
| Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations |  | Day 1 to Day 13 | 
| Safety measured by marked abnormalities in clinical laboratory test results |  | Day 1 to Day 13 |