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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: DCV 3DAA FDC

• Registration Number: NCT02095860
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

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

Primary Purpose:

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

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: DCV 3DAA FDC fasted state	DCV 3DAA FDC	DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state
Treatment B: DCV 3DAA FDC with high-fat meal	DCV 3DAA FDC	DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal
Treatment C: DCV 3DAA FDC with light meal	DCV 3DAA FDC	DCV 3DAA FDC tablet by mouth once on specified days with light meal

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety measured by abnormalities in vital sign measurements	Day 1 to Day 13
AUC(INF) for BMS-794712	Day 1 to Day 13
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
AUC(0-T) 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 marked abnormalities in clinical laboratory test results	Day 1 to Day 13
Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325	Day 1 to Day 13
Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations	Day 1 to Day 13
Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325	Day 1 to Day 13
Cmax for BMS-794712	Day 1 to Day 13
Tmax for BMS-794712	Day 1 to Day 13

Trial Locations

Locations (1)

Healthcare Discoveries, Llc D/B/A Icon Development Solutions; 🇺🇸 San Antonio, Texas, United States