A Study of RO5190591 (Danoprevir) in Healthy Volunteers

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01164488
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• 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: Jul 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: danoprevir; Repeated daily doses; Drug: ketoconazole; Repeated daily doses; Drug: ritonavir; Repeated daily doses

Outcome Measures

Primary Outcome Measures

1. To investigate the interaction between RO5190591/ritonavir and ketoconazole [Day 40]

Secondary Outcome Measures

1. To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole [Day 40]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01164488
• Other Study ID Numbers: NP25293
• First Posted: Jul 16, 2010
• Last Update Posted: Aug 29, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Ritonavir; Ketoconazole

Study Results

No Results Posted as of Aug 29, 2016