Expired Study
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Lenexa, Kansas 66219


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.


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


Study is Available At:


Original ID:

NP25293


NCT ID:

NCT01164488


Secondary ID:


Study Acronym:


Brief Title:

A Study of RO5190591 (Danoprevir) in Healthy Volunteers


Official Title:

A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

64 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:July 2010
Completion Date:August 2010
Completion Type:Actual
Primary Completion Date:August 2010
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 26, 2016
First Received Date:July 15, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:To investigate the interaction between RO5190591/ritonavir and ketoconazole
Time Frame:Day 40
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole
Time Frame:Day 40
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:danoprevir
Description:Repeated daily doses
Arm Name:1
Intervention Type:Drug
Name:ketoconazole
Description:Repeated daily doses
Arm Name:1
Intervention Type:Drug
Name:ritonavir
Description:Repeated daily doses
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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