A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

Hoffmann-La Roche33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteer

Interventions

danoprevirDRUG

single iv infusion

danoprevirDRUG

single oral dose

placeboDRUG

single iv infusion

ritonavir

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Pharmacokinetics: Area under the concentration-time curve (AUC)

Time frame: Pre-dose and up to 12 hours post-dose

Safety: Incidence of adverse events

Time frame: approximately 7 months

Data from ClinicalTrials.gov

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