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CompletedNCT01654211Updated Nov 2, 2016

A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

A Phase 1 interventional study of danoprevir and danoprevir in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women or males with female partners who are pregnant or lactating
  • Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
  • Positive for hepatitis B, hepatitis C or HIV infection
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Part 1: iv danoprevir

    Drug: danoprevir · Drug: ritonavir

  • Placebo comparator
    Part 1: placebo

    Drug: placebo · Drug: ritonavir

  • Experimental
    Part 2 A: iv danoprevir

    Drug: danoprevir · Drug: ritonavir

  • Active comparator
    Part 2 B: oral danoprevir

    Drug: danoprevir · Drug: ritonavir

  • Active comparator
    Part 2 C: ritonavir

    Drug: ritonavir

  • Experimental
    Part 3 D: iv danoprevir

    Drug: danoprevir · Drug: ritonavir

  • Experimental
    Part 3 E: iv danoprevir + cyclosporine

    Drug: danoprevir · Drug: ritonavir

Interventions

  • Drugdanoprevir

    single iv infusion

  • Drugdanoprevir

    single oral dose

  • Drugplacebo

    single iv infusion

  • Drugritonavir

    oral doses

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 12 hours post-dose

  2. Safety: Incidence of adverse events

    Time frame: approximately 7 months

07

Study locations

1 site
  • Zuidlaren, 9471 GP, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01654211
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 31, 2012
Start date
Jul 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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