A Study of RO5190591 (Danoprevir) in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ketoconazole; Ritonavir

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