Expired Study
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Lenexa, Kansas 66219


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.


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


NCT ID:

NCT01164488


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Lenexa, Kansas 66219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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