A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

A Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01654211

Enrollment

Registered

2012-07-31

Start date

2012-07-31

Completion date

2012-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGdanoprevir

single iv infusion

DRUGplacebo

single iv infusion

DRUGritonavir

oral doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026