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

Completed · Phase 1

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID: NCT02095860
Run by: Bristol-Myers Squibb
People needed: 24
Starts: 2014-04-01
Expected to finish: 2014-05-01
Last updated by the study team: 2014-10-10

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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