A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, two-part, open-label study designed to evaluate the effect of
      repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in
      healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet
      formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single
      sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be
      enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two
      occasions, once alone and once following administration of repeated doses of GSK2586184.
      Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3
      subjects to each treatment sequence). Each subject will receive a single dose of the standard
      formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once
      with food and once in a fasted state, according to their treatment sequence, with a 3-day
      wash out between doses. The primary aim of the study is to investigate the effects of
      GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with
      and without food on a new formulation of GSK2586184 tablet.
    


Intervention name(s): GSK2586184 standard formulation; Simvastatin; Rosuvastatin; GSK2586184 new formulation
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; GSK2586184; Simvastatin; Rosuvastatin; Poloxamer