A Study of RO5190591 (Danoprevir) in Healthy Volunteers - Full Text View

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: ritonavir Drug: ketoconazole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Ketoconazole

U.S. FDA Resources

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:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: danoprevir Repeated daily doses Drug: ritonavir Repeated daily doses Drug: ketoconazole Repeated daily doses

Eligibility


Ages Eligible for Study:	18 Years to 64 Years
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

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, see Learn About Clinical Studies.

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

No publications provided


Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01164488 History of Changes
Other Study ID Numbers:	NP25293
Study First Received:	July 15, 2010
Last Updated:	April 18, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Ketoconazole 14-alpha Demethylase Inhibitors Anti-Infective Agents Antifungal Agents	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015