A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: danoprevir; Drug: placebo; Drug: ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01654211

NP28297

2012-000470-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 7 patient groups, including a placebo group

Part 1: iv danoprevir

Experimental group

Treatment:

Drug: danoprevir

Drug: danoprevir

Drug: ritonavir

Part 1: placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: ritonavir

Part 2 A: iv danoprevir

Experimental group

Treatment:

Drug: danoprevir

Drug: danoprevir

Drug: ritonavir

Part 2 B: oral danoprevir

Active Comparator group

Treatment:

Drug: danoprevir

Drug: danoprevir

Drug: ritonavir

Part 2 C: ritonavir

Active Comparator group

Treatment:

Drug: ritonavir

Part 3 D: iv danoprevir

Experimental group

Treatment:

Drug: danoprevir

Drug: danoprevir

Drug: ritonavir

Part 3 E: iv danoprevir + cyclosporine

Experimental group

Treatment:

Drug: danoprevir

Drug: danoprevir

Drug: ritonavir