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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-09-02 |
| Est. Completion | 2014-08-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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