Skip to main content
OpenTrials
Completed

NCT Number: NCT01164488

A Study of RO5190591 (Danoprevir) in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danoprevir

Drug

Repeated daily doses

Ketoconazole

Drug

Repeated daily doses

Ritonavir

Drug

Repeated daily doses

Primary outcomes

  1. To investigate the interaction between RO5190591/ritonavir and ketoconazole

    Time frame: Day 40

Secondary outcomes

  1. To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole

    Time frame: Day 40

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2010
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.