A Study of RO5190591 (Danoprevir) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164488
First received: July 15, 2010
Last updated: April 18, 2012
Last verified: April 2012

July 15, 2010
April 18, 2012
July 2010
November 2010   (final data collection date for primary outcome measure)
To investigate the interaction between RO5190591/ritonavir and ketoconazole [ Time Frame: Day 40 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01164488 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5190591 (Danoprevir) in Healthy Volunteers
A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: danoprevir
    Repeated daily doses
  • Drug: ritonavir
    Repeated daily doses
  • Drug: ketoconazole
    Repeated daily doses
Experimental: 1
Interventions:
  • Drug: danoprevir
  • Drug: ritonavir
  • Drug: ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01164488
NP25293
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP