Conditions: Dyslipidaemias Dyslipidemias
Keywords: Pharmacodynamics Lipids Dyslipidemia Safety GSK1292263 Ezetimibe Statin Pharmacokinetics Tolerability Atorvastatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 287
Healthy volunteers: no

Brief summary:
This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken alone or when co-dosed with atorvastatin to subjects with dyslipidemia.

Detailed description:
This compound has been studied in healthy subjects and subjects with type II diabetes and is now being studied in subjects with dyslipidemia. Because many patients with dyslipidemia are on statins, it is important to study how GSK1292263 behaves when taken with a potent statin, atorvastatin. The cholesterol lowering drug, ezetimibe, is included for comparison.

Arms:
arm 1: Subjects on stable 40mg atorvastatin \> 4 weeks may raise their dose to 80mg for 2 weeks in order to qualify for Part A. arm 2: Dosing for 14 days arm 3: Washout for 4 weeks arm 4: Dosing for 4 weeks arm 5: Dosing for 4 weeks arm 6: Dosing for 14 days arm 7: Dosing for 14 days arm 8: Dosing for 14 days arm 9: Dosing for 14 days arm 10: Dosing for 14 days arm 11: Dosing for 14 days arm 12: Dosing for 14 days arm 13: Dosing for 14 days arm 14: Dosing for 14 days arm 15: Dosing for 14 days arm 16: Dosing for 14 days

Interventions: intervention 1: 10mg atorvastatin intervention 2: 80mg atorvastatin intervention 3: GSK1292263 Placebo intervention 4: 100mg GSK1292263 intervention 5: 300mg GSK1292263 intervention 6: 800mg GSK1292263 intervention 7: 10mg ezetimibe intervention 8: Washout
Intervention descriptions: intervention 1: 10mg intervention 2: 80mg intervention 3: Placebo intervention 4: 100mg intervention 5: 300mg intervention 6: 800mg intervention 7: 10mg intervention 8: No interventions - washout period

Protocol document: