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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT01844674 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Hoffmann-La Roche

909 total trials

What the finished NCT01844674 record still lists

NCT01844674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Vemurafenib is the first listed.

NCT01844674 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01844674's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01844674, the US trial registry maintained by the National Library of Medicine. NCT01844674 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.