Back to resultsDisturbed Sleep Model Study.
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SB-649868
Zolpidem
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
ADBC sequence
BACD sequence
CBDA sequence
DCAB sequence
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Secondary Outcome Measures
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00440323
Brief Title
Disturbed Sleep Model Study.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 5, 2007 (Actual)
Primary Completion Date
July 3, 2007 (Actual)
Study Completion Date
July 3, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADBC sequence
Arm Type
Experimental
Arm Description
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.
Arm Title
BACD sequence
Arm Type
Experimental
Arm Description
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.
Arm Title
CBDA sequence
Arm Type
Experimental
Arm Description
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.
Arm Title
DCAB sequence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SB-649868
Intervention Description
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Other Intervention Name(s)
SB-649868
Intervention Description
Zolpidem capsules will be available with dose strength of 10 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Primary Outcome Measure Information:
Title
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22237311
Citation
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.
Results Reference
derived
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Disturbed Sleep Model Study.
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