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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 3, 2012

Primary Completion Date

November 14, 2012

Study Completion Date

November 14, 2012

Conditions
Cancer
Interventions
DRUG

Warfarin

Warfarin dosed at 15mg on Day 1 and Day 22

DRUG

Ketoconazole

Ketoconazole dosed at 400mg daily on Days 19 through 22

DRUG

Gemfibrozil

Gemfibrozil dosed at 600mg twice daily on Days 19 through 22

DRUG

GSK2118436 150mg

GSK2118436 dosed at 150mg twice daily

DRUG

GSK2118436 75mg

GSK2118436 dosed at 75mg twice daily

Trial Locations (11)

6009

GSK Investigational Site, Nedlands

29605

GSK Investigational Site, Greenville

34232

GSK Investigational Site, Sarasota

37203

GSK Investigational Site, Nashville

43210

GSK Investigational Site, Columbus

48201

GSK Investigational Site, Detroit

73104

GSK Investigational Site, Oklahoma City

84112

GSK Investigational Site, Salt Lake City

85259

GSK Investigational Site, Scottsdale

OX3 7LJ

GSK Investigational Site, Headington

W1G 6AD

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY