A Study of RO5190591 (Danoprevir) in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

Repeated daily doses

ketoconazole

Intervention Type DRUG

Repeated daily doses

ritonavir

Intervention Type DRUG

Repeated daily doses

Interventions

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danoprevir

Repeated daily doses

Intervention Type DRUG

ketoconazole

Repeated daily doses

Intervention Type DRUG

ritonavir

Repeated daily doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes