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A Study of RO5190591 (Danoprevir) in Healthy Volunteers - NCT01164488-66219(Clinical Trial 702655)



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City:  Lenexa
State:  
KS
Zip Code: 66219
Conditions: Healthy Volunteer
Purpose: This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.
Study summary:
Criteria: Inclusion Criteria: - Adult healthy volunteers, aged 18-64 years, inclusively - Weight >/=50.0 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 48 hours prior to entry in the clinical study center until discharge - Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge - Medical history without major recent or ongoing pathology Exclusion Criteria: - Pregnant or lactating women and male partners of women who are pregnant or lactating - Sustained supine systolic blood pressure >140 or <90 mmHG and supine diastolic blood pressure >90 or <50 mmHG at Screening or Day -1 - Resting heart rate >100 or <45 beats per minute at Screening or Day -1 - Any history of clinically significant cardiovascular or cerebrovascular disease - Positive drug test result at screening or each admission - Donation or loss of blood over 450 ml (1 pint) within 60 days prior to screening
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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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