Status:
COMPLETED
A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Sub...
Eligibility Criteria
Inclusion
- Male and female healthy volunteers, 18 to 45 years of age inclusive
- Body mass index (BMI) 18.0 to 32.0 kg/m2
- Weight \>/= 50 kg
- Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- Nonsmoker
- Females of childbearing potential and males and their female partner(s) 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 (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)
Exclusion
- Pregnant or lactating females
- Positive results for drugs of abuse in the urine at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
- Current smokers or subjects who have discontinued smoking less than 6 months prior to the first dose of study medication
- Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
- Routine chronic use of more than 2 g acetaminophen daily
- Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
- History of clinically significant disease or disorder
- History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01514968
Start Date
December 1 2011
End Date
February 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Lenexa, Kansas, United States, 66219