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A Study of RO5190591 (Danoprevir) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01164488
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: danoprevir Drug: ketoconazole Drug: ritonavir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects
Study Start Date : July 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: danoprevir
Repeated daily doses
Drug: ketoconazole
Repeated daily doses
Drug: ritonavir
Repeated daily doses


Outcome Measures
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Primary Outcome Measures :
  1. To investigate the interaction between RO5190591/ritonavir and ketoconazole [ Time Frame: Day 40 ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole [ Time Frame: Day 40 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01164488     History of Changes
Other Study ID Numbers: NP25293
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Ritonavir
Ketoconazole
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
 Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs