Study Results
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Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2007-01-05
2007-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
Study Groups
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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.
SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
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.
SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
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.
SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
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.
SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Interventions
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SB-649868
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Zolpidem
Zolpidem capsules will be available with dose strength of 10 mg.
Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Abuse of alcohol.
* Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.
18 Years
55 Years
MALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Guildford, Surrey, United Kingdom
Countries
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References
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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.
Other Identifiers
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OXS104094
Identifier Type: -
Identifier Source: org_study_id
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