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A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 27, 2012
Last updated: November 1, 2016
Last verified: November 2016
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 Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: placebo
Drug: ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01654211

Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01654211     History of Changes
Other Study ID Numbers: NP28297
2012-000470-40 ( EudraCT Number )
Study First Received: July 27, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents processed this record on April 28, 2017