NCT01299597

A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.

Conditions

• Sleep Disorders

Interventions

Type	Name	Description
DRUG	Atorvastatin	20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.
DRUG	Simvastatin	10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.
DRUG	SB649868	20mg daily given for 14 days.

Timeline

• Start date: 2010-01-18
• Primary completion: 2010-02-26
• Completion: 2010-02-26
• First posted: 2011-02-18
• Last updated: 2017-07-21

Locations

1 site across 1 country: Germany