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.
Sponsor study identifier
interventional
52
1 country
1
Study Start
January 5, 2007
Actual (reported)Primary Completion
July 3, 2007
Actual (reported)Study Completion
July 3, 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 3, 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2007
Actual (reported)February 23, 2007
Actual (reported)February 27, 2007
Actual (reported)July 3, 2007
Actual (reported)July 3, 2007
Actual (reported)Total Sleep Time measured overnight across four treatment sessions (4 weeks)
4 weeks
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
4 weeks
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.
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.
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
GSK Investigational Site
Guildford, Surrey, GU2 7XP, United Kingdom
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.
GSK Clinical Trials
GlaxoSmithKline
52 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2007
First Posted
February 27, 2007
Study Start
January 5, 2007
Actual (reported)Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
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.
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.
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 3, 2007
Actual (reported)Study Completion
July 3, 2007
Actual (reported)Last Updated
August 17, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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