A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin

Summary

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

Timeline

Start

2010-09-14

Primary completion

2011-06-29

Completion

2011-06-29

Outcome

Mixed primary results

registry analysis (superiority or other test); Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo; Mean Difference (Net) -41.506 (95% CI -56.3924 to -26.6205) NCT01218204 ↗

registry analysis (superiority or other test); Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo; Mean Difference (Net) -12.123 (95% CI -26.6276 to 2.3814) NCT01218204 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	10 mg	Oral
Subject	Atorvastatin	Small molecule	80 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral
Subject	GSK1292263	Small molecule	100 mg	Oral
Subject	GSK1292263	Small molecule	300 mg	Oral
Subject	GSK1292263	Small molecule	800 mg	Oral

Indications