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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

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