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Tizanidine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Pharmacokinetic Population | EXPERIMENTAL | All participants will receive a 3-period treatment including single-dose tizanidine on Day 1, twice-daily vemurafenib on Days 2 to 21, and both agents together on Day 22. |
| Name | Type | Description |
|---|---|---|
| Tizanidine | DRUG | Participants will receive tizanidine as single oral doses, 2 milligrams (mg) on Day 1 and repeated on Day 22, each following an overnight fast \>/= 10 hours. |
| Vemurafenib | DRUG | Participants will receive vemurafenib as multiple oral doses, 960 mg twice daily on Days 2 to 22. |
Inclusion Criteria: * Adults 18 to 70 years of age, inclusive * Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing...
Tizanidine is a small molecule being studied in oncology for malignant melanoma and neoplasms. It is currently in Phase 1 clinical development, with one completed trial involving 18 patients with BRAFV600 mutation-positive metastatic malignancies. The drug is investigational and not yet approved for these indications.
Tizanidine is a small molecule, but its specific molecular target is not disclosed in the available information. It is being studied in oncology for malignant melanoma and neoplasms, particularly in combination with vemurafenib in patients with BRAFV600 mutation-positive metastatic malignancies.
Tizanidine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule for oncology indications, including malignant melanoma and neoplasms.
Tizanidine is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT01844674, which enrolled 18 patients. The drug is investigational and has not been approved by regulatory authorities for any indication.
Tizanidine has one completed clinical trial, NCT01844674, 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 Phase 1 study enrolled 18 patients across the United States, Brazil, Canada, Cyprus, and South Korea.