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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:May 2012
End Date:June 2012

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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.


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
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Lenexa, KS
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