NCT00495729

15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	SB-649868	Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.
DRUG	Placebo	Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.
DRUG	Simvastatin	Subjects will receive Simvastatin 10 mg tablets orally.

Timeline

• Start date: 2007-04-18
• Primary completion: 2007-08-04
• Completion: 2007-08-04
• First posted: 2007-07-03
• Last updated: 2017-08-08

Locations

1 site across 1 country: Germany