A Three Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low Dose Ritonavir (RTV), a Drug-Drug Interaction Study Between IV DNV/Oral Low Dose RTV and Oral Cyclosporine, and the Absolute Bioavailability of IV DNV as Compared to DNV Tablets Together With Oral Low Dose RTV in Healthy Adult Volunteers
Completed
- Conditions
- Chronic Hepatitis CJaundice10047438
- Registration Number
- NL-OMON37643
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
Inclusion Criteria
healthy male or female subjects
18-55 yrs, inclusive
BMI: 18.0-32.0 kg/m2, inclusive
Weight: * 50.0 kg
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics :<br /><br>Part 1: Plasma drug concentrations for DNV (following IV administration) and<br /><br>RTV.<br /><br>Part 2: Plasma drug concentrations for DNV (following oral and IV<br /><br>administration) and RTV.<br /><br>Part 3: Plasma drug concentrations for DNV (following IV administration), RTV,<br /><br>and cyclosporine.<br /><br><br /><br>Urine drug concentrations for DNV and RTV (Parts 2 and 3), and<br /><br>cyclosporine (Part 3 only).</p><br>
- Secondary Outcome Measures
Name Time Method <p>AEs, vital signs, 12-lead ECGs, clinical laboratory testing</p><br>