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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: atazanavir (Drug); danoprevir (Drug); ritonavir (Drug); tenofovir disoproxil fumarate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC)

Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC)

Secondary outcome: Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Lenexa, Kansas 66219, United States
Additional Information

Starting date: May 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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