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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: DCV 3DAA FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095860

AI443-111

Details and patient eligibility

About

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.

Full description

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

Primary Purpose:

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

24 participants in 3 patient groups

Treatment A: DCV 3DAA FDC fasted state

Experimental group

Description:

DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state

Treatment:

Drug: DCV 3DAA FDC

Treatment B: DCV 3DAA FDC with high-fat meal

Experimental group

Description:

DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal

Treatment:

Drug: DCV 3DAA FDC

Treatment C: DCV 3DAA FDC with light meal

Experimental group

Description:

DCV 3DAA FDC tablet by mouth once on specified days with light meal

Treatment:

Drug: DCV 3DAA FDC