A Study of RO5190591 (Danoprevir) in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT01164488
- Run by
- Hoffmann-La Roche
- People needed
- 18
- Starts
- 2010-07-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2016-08-29
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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