An Open Label Study to Examine the Effects of a High-Fat Meal and Particle Size on the Pharmacokinetics of Orally Administered GSK2118436 in Subjects With BRAF Mutation Positive Tumor

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 21, 2010

Primary Completion Date

May 13, 2011

Study Completion Date

May 13, 2011

Conditions
Cancer
Interventions
DRUG

Regimen A

Two gelatin capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed fasted

DRUG

Regimen B

Two gelatin capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, larger, non-micronized particles, equivalent to 150 mg free base), dosed fasted

DRUG

Regimen C

Two Hydroxy Propyl Methyl Cellulose (HPMC) capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed fasted

DRUG

Regimen D

Two HPMC capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed with a high-fat meal

Trial Locations (4)

37203

GSK Investigational Site, Nashville

48201

GSK Investigational Site, Detroit

84112

GSK Investigational Site, Salt Lake City

85259

GSK Investigational Site, Scottsdale

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY