A Study of RO5190591 (Danoprevir) in Healthy Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01164488 |
Recruitment Status
:
Completed
First Posted
: July 16, 2010
Last Update Posted
: August 29, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteer | Drug: danoprevir Drug: ketoconazole Drug: ritonavir | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: danoprevir
Repeated daily doses
Drug: ketoconazole
Repeated daily doses
Drug: ritonavir
Repeated daily doses
|
- To investigate the interaction between RO5190591/ritonavir and ketoconazole [ Time Frame: Day 40 ]
- To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole [ Time Frame: Day 40 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Kansas | |
Lenexa, Kansas, United States, 66219 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |