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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095860
• Other study ID #: AI443-111
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2014
• Last updated: October 9, 2014
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Primary Purpose:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• DCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325

Locations

Country	Name	City	State
United States	Healthcare Discoveries, Llc D/B/A Icon Development Solutions	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325		Day 1 to Day 13	No
Primary	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	No
Secondary	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	No
Secondary	Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325		Day 1 to Day 13	No
Secondary	Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325		Day 1 to Day 13	No
Secondary	AUC(0-T) for BMS-794712		Day 1 to Day 13	No
Secondary	AUC(INF) for BMS-794712		Day 1 to Day 13	No
Secondary	Cmax for BMS-794712		Day 1 to Day 13	No
Secondary	Tmax for BMS-794712		Day 1 to Day 13	No
Secondary	T-HALF for BMS-794712		Day 1 to Day 13	No
Secondary	Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation		Day 1 to Day 13	Yes
Secondary	Safety measured by abnormalities in vital sign measurements		Day 1 to Day 13	Yes
Secondary	Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations		Day 1 to Day 13	Yes
Secondary	Safety measured by marked abnormalities in clinical laboratory test results		Day 1 to Day 13	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form