A Study of RO5190591 (Danoprevir) in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ketoconazole

Drug: ritonavir

Drug: danoprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01164488

NP25293

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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