A Study of RO5190591 (Danoprevir) in Healthy Volunteers

NCT01164488 | Completed Phase 1

• 1 other identifier: NP25293
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• To investigate the interaction between RO5190591/ritonavir and ketoconazole

  Day 40

Secondary Outcomes (1)

• To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole

  Day 40

Study Arms (1)

1

EXPERIMENTAL

Drug: danoprevir; Drug: ketoconazole; Drug: ritonavir

Interventions

danoprevir DRUG

Repeated daily doses

1

ketoconazole DRUG

Repeated daily doses

1

ritonavir DRUG

Repeated daily doses

1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

danoprevir; Ketoconazole; Ritonavir

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

US (1)