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NCT01588002 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01588002 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants.

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The verdict

NCT01588002, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

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.

Interventions

  • DRUG ritonavir
  • DRUG efavirenz
  • DRUG danoprevir

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-04
Est. Completion 2012-06
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01588002

The ClinicalTrials.gov registry entry for NCT01588002 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which ritonavir is the first listed.

NCT01588002 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01588002 about?

NCT01588002 is a clinical study titled "A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers". 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 da...

What is the current status of trial NCT01588002?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-04. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01588002?

The interventions under investigation include: ritonavir (DRUG), efavirenz (DRUG), danoprevir (DRUG).

Who is sponsoring clinical trial NCT01588002?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.