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A Study of RO5190591 (Danoprevir) in Healthy Volunteers

A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164488
Enrollment
18
Registered
2010-07-16
Start date
2010-07-31
Completion date
2010-08-31
Last updated
2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGdanoprevir

Repeated daily doses

DRUGketoconazole

Repeated daily doses

DRUGritonavir

Repeated daily doses

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frame
To investigate the interaction between RO5190591/ritonavir and ketoconazoleDay 40

Secondary

MeasureTime frame
To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazoleDay 40

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026