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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: DCV 3DAA FDC

Detailed Description

IND Number: 100,932/79,599/101,943

Primary Purpose:

Other: Phase 1 clinical pharmacology bioavailability study to assess food effect

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Healthcare Discoveries, Llc D/B/A Icon Development Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: DCV 3DAA FDC fasted state; DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state	Drug: DCV 3DAA FDC; Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Experimental: Treatment B: DCV 3DAA FDC with high-fat meal; DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal	Drug: DCV 3DAA FDC; Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Experimental: Treatment C: DCV 3DAA FDC with light meal; DCV 3DAA FDC tablet by mouth once on specified days with light meal	Drug: DCV 3DAA FDC; Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: AI443-111