A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01654211
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
Exclusion Criteria
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: iv danoprevir danoprevir - Part 1: placebo placebo - Part 1: iv danoprevir ritonavir - Part 1: placebo ritonavir - Part 2 A: iv danoprevir danoprevir - Part 2 A: iv danoprevir ritonavir - Part 2 B: oral danoprevir danoprevir - Part 2 B: oral danoprevir ritonavir - Part 3 D: iv danoprevir ritonavir - Part 2 C: ritonavir ritonavir - Part 3 D: iv danoprevir danoprevir - Part 3 E: iv danoprevir + cyclosporine danoprevir - Part 3 E: iv danoprevir + cyclosporine ritonavir -
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Area under the concentration-time curve (AUC) Pre-dose and up to 12 hours post-dose Safety: Incidence of adverse events approximately 7 months
- Secondary Outcome Measures
Name Time Method