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: | 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: | 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) |
| 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
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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
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 |
| Health Authority: | United States: Food and Drug Administration |
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 September 23, 2016