A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 4, 2013

Primary Completion Date

March 10, 2014

Study Completion Date

March 10, 2014

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

GSK2586184 standard formulation

GSK2586184 standard formulation is a white film coated round biconvex 200 mg oral tablet. For cohort A, it is to be administered at 400 mg (200 mg x 2 tablets) twice daily from Day 6 to Day 14. For cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose after standard breakfast either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day wash out period.

DRUG

Simvastatin

Simvastatin 10 mg oral tablet is peach-coloured, oval-shaped tablets. It is to be administered orally as a single dose of 10 mg tablet on the mornings of Day 1 and Day 10.

DRUG

Rosuvastatin

GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period.

DRUG

GSK2586184 new formulation

GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period.

Trial Locations (1)

21225

GSK Investigational Site, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY