Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01340846
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2011-04-14
Brief Title:
A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin the Effects of Ketoconazole and Gemfibrozil on GSK2118436 and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Four-Part Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436 and the Repeat Dose Pharmacokinetics of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GSK2118436 is an orally administered potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors This is a 4-part study in 4 separate cohorts of subjects designed to examine the interaction potential of GSK2118436 either as a perpetrator ie effect of GSK2118436 on warfarin Part A or victim ie effect of other drugs on GSK2118436 Part B ketoconazole and Part C gemfibrozil as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 Part D A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A Part B Part C and Part D Following completion of this study subjects may continue dosing with GSK2118436 in the roll-over study Protocol BRF114144
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None