Skip to main content
OpenTrials
Completed

NCT Number: NCT02095860

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries, Llc D/B/A Icon Development Solutions

San Antonio, Texas, 78209, United States

About this study

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

Primary Purpose:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCV 3DAA FDC

Drug

Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325

    Time frame: Day 1 to Day 13

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325

    Time frame: Day 1 to Day 13

Secondary outcomes

  1. 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

    Time frame: Day 1 to Day 13

  2. Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325

    Time frame: Day 1 to Day 13

  3. Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325

    Time frame: Day 1 to Day 13

  4. AUC(0-T) for BMS-794712

    Time frame: Day 1 to Day 13

  5. AUC(INF) for BMS-794712

    Time frame: Day 1 to Day 13

  6. Cmax for BMS-794712

    Time frame: Day 1 to Day 13

  7. Tmax for BMS-794712

    Time frame: Day 1 to Day 13

  8. T-HALF for BMS-794712

    Time frame: Day 1 to Day 13

  9. Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation

    Time frame: Day 1 to Day 13

  10. Safety measured by abnormalities in vital sign measurements

    Time frame: Day 1 to Day 13

  11. Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations

    Time frame: Day 1 to Day 13

  12. Safety measured by marked abnormalities in clinical laboratory test results

    Time frame: Day 1 to Day 13

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.