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CompletedNCT01519336Updated Nov 2, 2016

A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

A Phase 1 interventional study of danoprevir and darunavir 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
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.

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

  • Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
  • Healthy status defined by absence of evidence of any active or chronic disease
  • Medical history without major, recent, or ongoing pathology
  • Weight >/= 55 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 72 hours prior to entry in the clinical site center until discharge
  • Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating females or males with female partners who are pregnant or lactating
  • Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
  • Positive test 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 within 30 days before the first dose of study medication
  • History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
05

Study design

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

Study arms

  • Active comparator
    A danoprevir

    Drug: danoprevir · Drug: ritonavir

  • Placebo comparator
    B darunavir

    Drug: darunavir · Drug: ritonavir

  • Experimental
    C danoprevir/darunavir

    Drug: danoprevir · Drug: darunavir · Drug: ritonavir

Interventions

  • Drugdanoprevir

    100 mg q12h

  • Drugdarunavir

    600 mg q12h

  • Drugritonavir

    100 mg q12h

06

What researchers measure

Primary outcomes

  1. Effect of coadministration of darunavir (DRV), danoprevir (DNV) and ritonavir (RTV) on DRV/DNV/RTV pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: approximately 2 months

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 2 months

07

Study locations

1 site
  • Lenexa, Kansas 66219, United States
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
NCT01519336
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 26, 2012
Start date
Feb 2012
Primary completion
Mar 2012
Completion
Mar 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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