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A Study of RO5190591 (Danoprevir) in Healthy Volunteers
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164488
First received: July 15, 2010
Last updated: August 26, 2016
Last verified: August 2016
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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: ketoconazole Drug: ritonavir | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 ]
Secondary Outcome Measures:
- To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole [ Time Frame: Day 40 ]
| Enrollment: | 18 |
| Study Start Date: | July 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: danoprevir
Repeated daily doses
Drug: ketoconazole
Repeated daily doses
Drug: ritonavir
Repeated daily doses
|
Eligibility| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164488
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
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01164488 History of Changes |
| Other Study ID Numbers: |
NP25293 |
| Study First Received: | July 15, 2010 |
| Last Updated: | August 26, 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 |
ClinicalTrials.gov processed this record on June 26, 2017