A Phase I/IIa Study Assessing Single and Multiple Doses of study drug in Healthy and Genotype 1 HCV-Infected Subjects
- Conditions
- Hepatitis Cinfectious liverdisease10047438
- Registration Number
- NL-OMON35061
- Lead Sponsor
- Idenix Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Antiviral Activity; Parameters:<br /><br>* Change in plasma HCV RNA<br /><br>* Emergence of resistance mutations<br /><br><br /><br>Pharmacokinetic; Parameters:<br /><br>* Concentrations of IDX320 in plasma and urine<br /><br><br /><br>Safety; Parameters:<br /><br>* Adverse events, physical examination, vital signs, 12-lead ECG and standard<br /><br>safety laboratory tests</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>