Clinical trial NCT02095860: Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
timeFrame: Day 1 to Day 13
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325
timeFrame: Day 1 to Day 13
Secondary outcomes:
measure: 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
timeFrame: Day 1 to Day 13
measure: Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325
timeFrame: Day 1 to Day 13
measure: Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325
timeFrame: Day 1 to Day 13
measure: AUC(0-T) for BMS-794712
timeFrame: Day 1 to Day 13
measure: AUC(INF) for BMS-794712
timeFrame: Day 1 to Day 13
measure: Cmax for BMS-794712
timeFrame: Day 1 to Day 13
measure: Tmax for BMS-794712
timeFrame: Day 1 to Day 13
measure: T-HALF for BMS-794712
timeFrame: Day 1 to Day 13
measure: Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation
timeFrame: Day 1 to Day 13
measure: Safety measured by abnormalities in vital sign measurements
timeFrame: Day 1 to Day 13
measure: Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations
timeFrame: Day 1 to Day 13
measure: Safety measured by marked abnormalities in clinical laboratory test results
timeFrame: Day 1 to Day 13
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries, Llc D/B/A Icon Development Solutions
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: