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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
History of Changes
  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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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
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
Ritonavir
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on May 23, 2013