NCT01030939

Study to Investigate Safety, Tolerability, Pharmacokinetics and Cardiac Function After Repeat Doses of SB-649868 in Healthy-volunteers

A Single-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate Safety, Tolerability, Pharmacokinetics and the Effects on Cardiac Function of Repeat Oral Doses of SB-649868 in Adult and Elderly Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether SB-649868 is safe, tolerable after repeated administrations in adult and elderly healthy volunteers. Pharmacokinetics and effects on cardiac function of repeated doses are studied

Detailed description

The present clinical study will assess safety, tolerability and pharmacokinetics of SB-649868 20mg administered for 28 consecutive days in adult (18 to 65 yrs old) and elderly (\>65 yrs old) men and women. The study will also assess cardiac function using echocardiography.

Conditions

• Sleep Disorders

Interventions

Type	Name	Description
DRUG	SB-649868	In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo

Timeline

• Start date: 2009-08-27
• Primary completion: 2010-01-06
• Completion: 2010-01-06
• First posted: 2009-12-14
• Last updated: 2017-06-20

Locations

1 site across 1 country: Germany