Status:
COMPLETED
A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir ...
Eligibility Criteria
Inclusion
- Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
- Healthy status defined by absence of evidence of any active or chronic disease
- Medical history without major, recent, or ongoing pathology
- Weight \>/= 55 kg
- Body mass index (BMI) 18.0 - 32.0 kg/m2
- Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 72 hours prior to entry in the clinical site center until discharge
- Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide
Exclusion
- Pregnant or lactating females or males with female partners who are pregnant or lactating
- Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
- Positive test for drugs of abuse 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 first dose of study medication
- Use of hormonal contraceptives within 30 days before the first dose of study medication
- History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01519336
Start Date
February 1 2012
End Date
March 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Lenexa, Kansas, United States, 66219