NCT01218204

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidaemias
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	10mg atorvastatin	10mg
DRUG	80mg atorvastatin	80mg
DRUG	GSK1292263 Placebo	Placebo
DRUG	100mg GSK1292263	100mg
DRUG	300mg GSK1292263	300mg
DRUG	800mg GSK1292263	800mg
DRUG	10mg ezetimibe	10mg
OTHER	Washout	No interventions - washout period

Timeline

• Start date: 2010-09-14
• Primary completion: 2011-06-29
• Completion: 2011-06-29
• First posted: 2010-10-11
• Last updated: 2019-07-16
• Results posted: 2017-11-08

Locations

21 sites across 1 country: United States