Disturbed Sleep Model Study.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: SB-649868 (Drug); Zolpidem (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG
nights, study drug administration and noise model is conducted on second night.
Clinical Details
Official title: A Double-Blind, Double-Dummy, Randomised, Placebo-Controlled,Four-Way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Total Sleep Time measured overnight
across four treatment sessions (4 weeks)
Secondary outcome: The effects on daytime cognitive function following dosing
across four treatment sessions (4 weeks)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Body weight =50 kg and BMI within the range 18. 5-29. 9 kg/m2 inclusive
- Healthy as judged by responsible physician.
- No clinically significant abnormality identified on the medical or laboratory
evaluation and 12-lead ECG;
- The subject shows a normal sleep pattern on the basis of the evaluation of both PSG
screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence
Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg
movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the
number of apneas and hyponeas divided by the total sleep time (TST) expressed in
hours". PLMI is defined as "the number of periodic leg movements associated with
arousals or awakening divided by the total sleep time (TST) expressed in hour".
Exclusion Criteria:
- A positive result for the pre-study urine drug/ alcohol breath screen.
- Abuse of alcohol.
- Subject complains of sleep disturbances and /or is receiving treatment for sleep
disorders.
Locations and Contacts
GSK Clinical Trials Call Center, Guildford GU2 7XP, United Kingdom
Additional Information
Starting date: January 2007
Last updated: September 17, 2007
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