A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01654211
First received: July 27, 2012
Last updated: April 7, 2014
Last verified: April 2014
  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: ritonavir
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 7 months ] [ Designated as safety issue: No ]

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: ritonavir
oral doses
Drug: placebo
single iv infusion
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654211

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01654211     History of Changes
Other Study ID Numbers: NP28297, 2012-000470-40
Study First Received: July 27, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporins
Ritonavir
Lactams
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014