A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01654211

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir Drug: danoprevir Drug: placebo Drug: ritonavir	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: iv danoprevir	Drug: danoprevir single iv infusion Drug: ritonavir oral doses
Placebo Comparator: Part 1: placebo	Drug: placebo single iv infusion Drug: ritonavir oral doses
Experimental: Part 2 A: iv danoprevir	Drug: danoprevir single iv infusion Drug: ritonavir oral doses
Active Comparator: Part 2 B: oral danoprevir	Drug: danoprevir single oral dose Drug: ritonavir oral doses
Active Comparator: Part 2 C: ritonavir	Drug: ritonavir oral doses
Experimental: Part 3 D: iv danoprevir	Drug: danoprevir single iv infusion Drug: ritonavir oral doses
Experimental: Part 3 E: iv danoprevir + cyclosporine	Drug: danoprevir single iv infusion Drug: ritonavir oral doses

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Zuidlaren		Netherlands	9471 GP

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01654211

Other Study ID Numbers:

NP28297
2012-000470-40

First Posted:

Jul 31, 2012

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Ritonavir

Lactams

Study Results

No Results Posted as of Nov 2, 2016