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Disturbed Sleep Model Study.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00440323
First received: February 23, 2007
Last updated: August 15, 2017
Last verified: August 2017
February 23, 2007
August 15, 2017
January 5, 2007
July 3, 2007   (Final data collection date for primary outcome measure)
Total Sleep Time measured overnight across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Complete list of historical versions of study NCT00440323 on ClinicalTrials.gov Archive Site
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Not Provided
Not Provided
 
Disturbed Sleep Model Study.
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: SB-649868
    SB-649868 tablets will be available with dose strength of 5 and 25 mg.
  • Drug: Zolpidem
    Zolpidem capsules will be available with dose strength of 10 mg.
    Other Name: SB-649868
  • Drug: Placebo
    Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
  • Experimental: ADBC sequence
    In ADBC sequence A is Placebo, B is SB-649868 10 milligram (mg), C is SB-649868 30 mg, and D is Zolpidem 10 mg. Subject will receive placebo tablets, then two 5 mg tablets of SB-649868, then 25 mg and 5 mg tablet of SB-649868. There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: BACD sequence
    In BACD sequence subject will receive SB-649868 two tablets of 5 mg each (10 mg, B), Placebo tablets (A), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), and Zolpidem 10 mg (D). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: CBDA sequence
    In CBDA sequence subject will receive SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), SB-649868 two tablets of 5 mg each (10 mg, B), Zolpidem 10 mg (D) and Placebo tablet (A). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: DCAB sequence
    In DCAB sequence subject will receive Zolpidem 10 mg (D), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), Placebo tablet (A), and SB-649868 two tablets of 5 mg each (10 mg, B). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
Bettica P, Squassante L, Groeger JA, Gennery B, Winsky-Sommerer R, Dijk DJ. Differential effects of a dual orexin receptor antagonist (SB-649868) and zolpidem on sleep initiation and consolidation, SWS, REM sleep, and EEG power spectra in a model of situational insomnia. Neuropsychopharmacology. 2012 Apr;37(5):1224-33. doi: 10.1038/npp.2011.310. Epub 2012 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 3, 2007
July 3, 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00440323
OXS104094
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP