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A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

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ClinicalTrials.gov Identifier: NCT01592305
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

April 24, 2012
May 7, 2012
November 2, 2016
May 2012
June 2012   (Final data collection date for primary outcome measure)
  • Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20 ]
  • Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20 ]
Same as current
Complete list of historical versions of study NCT01592305 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: approximately 2 months ]
Same as current
Not Provided
Not Provided
 
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers
This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.
Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy Volunteer
  • Drug: atazanavir
    multiple oral doses
  • Drug: danoprevir
    multiple oral doses
  • Drug: ritonavir
    multiple oral doses
  • Drug: tenofovir disoproxil fumarate
    single oral doses
  • Experimental: S1 P1 TDF + DNV/r
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
    • Drug: tenofovir disoproxil fumarate
  • Experimental: S1/S2 P2 DNV/r + ATZ
    Interventions:
    • Drug: atazanavir
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: S2 P1 ATZ/r
    Interventions:
    • Drug: atazanavir
    • 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
40
Same as current
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female volunteers, 18 to 55 years of age, inclusive
  • Body weight >/= 55 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 disease or condition
  • Positive for drugs of abuse at screening or prior to admission to the clinical site
  • 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 pill, patches, or 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 allergy reaction
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592305
NP28104
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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