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A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654211
First Posted: July 31, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654211


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01654211     History of Changes
Other Study ID Numbers: NP28297
2012-000470-40 ( EudraCT Number )
First Submitted: July 27, 2012
First Posted: July 31, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ritonavir
Cyclosporine
Lactams
Cyclosporins
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Bacterial Agents