A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592318
First received: April 24, 2012
Last updated: September 22, 2014
Last verified: September 2014

April 24, 2012
September 22, 2014
May 2012
June 2012   (final data collection date for primary outcome measure)
  • Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01592318 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers

This randomized, open-label, crossover study will evaluate the relative bioavail ability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or d anoprevir and ritonavir as separate tablets. In a crossover design, subjects wil l participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to re ference tablets.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: danoprevir
    Fixed dose combination tablet with ritonavir, single oral dose
  • Drug: danoprevir
    Reference tablet, single oral dose
  • Drug: ritonavir
    Fixed dose combination tablet with danoprevir, single oral dose
  • Drug: ritonavir
    Reference tablet, single oral dose
  • Active Comparator: DNV + r reference
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: DNV/r fixed dose combination
    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
42
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female volunteers, 18 to 55 years of age
  • Body weight >/= 50.0 kg
  • Body mass index (BMI) 18.0 - 32.0 kg/m2
  • Healthy non-smoking subjects. 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
  • 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, 1 of which must be a barrier method, 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
  • Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
  • Positive result 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
  • Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
  • Use of hormonal contraceptives (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication
  • Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
  • History of drug-related allergic reactions or hepatotoxicity
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01592318
NP28136
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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