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CompletedNCT01588002Updated Nov 2, 2016

A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

A Phase 1 interventional study of danoprevir and efavirenz in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. 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
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.

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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

  • Healthy male and female non-smoking subjects, 18 to 55 years of age
  • 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
  • Medical history without major, recent or ongoing pathology
  • Weight >/= 50.0 kg
  • Body mass index (BMI) 18.0 - 32.0 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women or males with female partners who are pregnant or lactating
  • History of any clinically significant medical condition which may impact the safety of the participant
  • 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
  • Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
  • Use of hormonal contraceptives (e.g. birth control pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
  • Use of investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
  • History of drug-related allergic reaction
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    A danoprevir+ritonavir

    Drug: danoprevir · Drug: ritonavir

  • Active comparator
    B efavirenz

    Drug: efavirenz

  • Experimental
    C combination

    Drug: danoprevir · Drug: efavirenz · Drug: ritonavir

Interventions

  • Drugdanoprevir

    multiple oral doses

  • Drugefavirenz

    multiple oral doses

  • Drugritonavir

    multiple oral doses

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What researchers measure

Primary outcomes

  1. Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax

    Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28

  2. Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 2 months

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Study locations

1 site
  • Lenexa, Kansas 66219, United States
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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 ↗
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Registry details

Key details

Study ID
NCT01588002
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
Apr 2012
Primary completion
Jun 2012
Completion
Jun 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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