NCT01164488CompletedPhase 1
A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 18
- Primary Endpoint
- To investigate the interaction between RO5190591/ritonavir and ketoconazole
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Intervention: danoprevir (Drug)
1
Experimental
Intervention: ketoconazole (Drug)
1
Experimental
Intervention: ritonavir (Drug)
Outcomes
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(Day 40)
Investigators
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