A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483729
First received: November 30, 2011
Last updated: August 4, 2014
Last verified: August 2014

November 30, 2011
August 4, 2014
December 2011
January 2012   (final data collection date for primary outcome measure)
  • Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01483729 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
Not Provided

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in health y volunteers. In Part 1, subjects will be randomized to receive single oral dose s of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subject s will be randomized to receive single oral doses of one of three tablet formula tions of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: danoprevir
    Phase 3 Tablet Formulation 1, single oral dose
  • Drug: danoprevir
    Phase 3 Tablet Formulation 2, single oral dose
  • Drug: danoprevir
    Reference Phase 2 Tablet Formulation, single oral dose
  • Drug: ritonavir
    Test Formulation 1, single oral dose
  • Drug: ritonavir
    Test Formulation 2, single oral dose
  • Drug: ritonavir
    Reference Formulation, single oral dose
  • Active Comparator: Part 1 A
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Part 1 B
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Part 1 C
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Active Comparator: Part 2 D
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Part 2 E
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Part 2 F
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers, 18 to 45 years of age inclusive
  • Body mass index 18.0 - 32.0 kg/m2, weight >/= 50 kg
  • Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
  • Non-smoker
  • Medical history without major, recent or ongoing pathology
  • Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration

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
  • Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
  • Routine use of more than 2 g of acetaminophen daily
  • History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
  • History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
  • Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01483729
NP27945, RPU425UD-114254
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP