Lenexa, Kansas, 66219, United States
NCT Number: NCT01164488
A Study of RO5190591 (Danoprevir) in Healthy Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Danoprevir
DrugRepeated daily doses
Ketoconazole
DrugRepeated daily doses
Ritonavir
DrugRepeated daily doses
Primary outcomes
-
To investigate the interaction between RO5190591/ritonavir and ketoconazole
Time frame: Day 40
Secondary outcomes
-
To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole
Time frame: Day 40
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Jul 16, 2010
- Registry last updated
- Aug 29, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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