Hepatitis C infectious liverdisease
Conditions
Interventions
Part A (healthy subjects)
Group 1: a single oral dose of 50 mg study drug or placebo on Day 1 in the fed
state.
Group 2: a single oral dose of 100 mg study drug or placebo on Day 1 in the fed
state.
Sponsors
Idenix Pharmaceuticals Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18-65 years of age, inclusive (or the legal age of consent per local regulations). 2.Body Mass Index (BMI) 18-35 kg/m2 3.Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control from first dose through at least 90 days after the last dose of the study drug. 4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug. 5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study. 6.Pulse * 40 BPM, systolic blood pressure * 95 mmHg and QTcF interval * 450 ms at screening and Day -1. 7. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements. 8.Subject has provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antiviral Activity; Parameters: * Change in plasma HCV RNA * Emergence of resistance mutations Pharmacokinetic; Parameters: * Concentrations of IDX320 in plasma and urine Safety; Parameters: * Adverse events, physical examination, vital signs, 12-lead ECG and standard safety laboratory tests | — |
Countries
Netherlands
Outcome results
None listed