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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592305
First received: April 24, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: ritonavir
Drug: tenofovir disoproxil fumarate
Drug: atazanavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S1 P1 TDF + DNV/r Drug: danoprevir
multiple oral doses
Drug: ritonavir
multiple oral doses
Drug: tenofovir disoproxil fumarate
single oral doses
Experimental: S2 P1 ATZ/r Drug: ritonavir
multiple oral doses
Drug: atazanavir
multiple oral doses
Experimental: S1/S2 P2 DNV/r + ATZ Drug: danoprevir
multiple oral doses
Drug: ritonavir
multiple oral doses
Drug: atazanavir
multiple oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592305

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
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: NCT01592305     History of Changes
Other Study ID Numbers: NP28104
Study First Received: April 24, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ritonavir
Atazanavir
Tenofovir
Tenofovir disoproxil
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014