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OpenTrials
Completed

NCT Number: NCT00440323

Disturbed Sleep Model Study.

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Guildford, Surrey, GU2 7XP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-649868

Drug

SB-649868 tablets will be available with dose strength of 5 and 25 mg.

zolpidem

Drug

Zolpidem capsules will be available with dose strength of 10 mg.

Other names: SB-649868

Placebo

Drug

Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.

Primary outcomes

  1. Total Sleep Time measured overnight across four treatment sessions (4 weeks)

    Time frame: 4 weeks

Secondary outcomes

  1. The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2007
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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