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 |
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.
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
We found this trial at
1
site
Click here to add this to my saved trials