NCT01376232

Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)

Open Label Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),\]

Detailed description

The purpose of this study is to assess the clinical drug-drug interaction potential of GSK1278863A with medications that are inhibitors of CYP2C8 enzyme in order to support co-administration of similar agents in later phase development. Specifically. this study will assess the pharmacokinetics of a single dose of GSK1278863A administered alone or co-administered with gemfibrozil, a potent inhibitor of CYP2C8, following steady-state oral administration of gemfibrozil. Finally, to support the co-administration of GSK1278863A with food, this study will assess the pharmacokinetics of a single oral dose of GSK1278863A under fasting conditions and following a standard high-calorie, high fat meal.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863	GSk1278863 100mg
DRUG	GSK1278863 + food	High Fat meal + 100 mg GSK1278863
DRUG	Gemfibrozil	600 mg Gemfibrozil

Timeline

• Start date: 2010-11-08
• Primary completion: 2010-12-20
• Completion: 2010-12-20
• First posted: 2011-06-20
• Last updated: 2017-06-09

Locations

1 site across 1 country: India