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NCT01844674 · ClinicalTrials.gov registry record · Phase 1

A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

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

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT01844674 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 18 participants.

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The verdict

NCT01844674, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dose of tizanidine on Day 1, vemurafenib orally twice daily on Days 2 to 21, and tizanidine and vemurafenib on Day 22. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).

Interventions

  • DRUG Vemurafenib
  • DRUG Tizanidine

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2013-09-02
Est. Completion 2014-08-26
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01844674

The ClinicalTrials.gov registry entry for NCT01844674 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 2 interventions - of which Vemurafenib is the first listed.

NCT01844674 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01844674 about?

NCT01844674 is a clinical study titled "A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies". This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single oral dos...

What is the current status of trial NCT01844674?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2013-09-02. Estimated completion is 2014-08-26.

What interventions are being tested in trial NCT01844674?

The interventions under investigation include: Vemurafenib (DRUG), Tizanidine (DRUG).

Who is sponsoring clinical trial NCT01844674?

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 Editorial

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.