Status:
COMPLETED
A Study of RO5190591 (Danoprevir) in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01164488
Start Date
July 1 2010
End Date
August 1 2010
Last Update
August 29 2016
Active Locations (1)
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1
Lenexa, Kansas, United States, 66219