A Study of RO5190591 (Danoprevir) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: danoprevir; Drug: ketoconazole; Drug: ritonavir

• Registration Number: NCT01164488
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	danoprevir	-
1	ketoconazole	-
1	ritonavir	-

Primary Outcome Measures

Name	Time	Method
To investigate the interaction between RO5190591/ritonavir and ketoconazole	Day 40

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole	Day 40