A Study of RO5190591 (Danoprevir) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164488
First received: July 15, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: ritonavir
Drug: ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • To investigate the interaction between RO5190591/ritonavir and ketoconazole [ Time Frame: Day 40 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole [ Time Frame: Day 40 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: danoprevir
Repeated daily doses
Drug: ritonavir
Repeated daily doses
Drug: ketoconazole
Repeated daily doses

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164488

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01164488     History of Changes
Other Study ID Numbers: NP25293
Study First Received: July 15, 2010
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014