Disturbed Sleep Model Study.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: SB-649868
* Drug: Zolpidem
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADBC sequence<br>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. | Drug: SB-649868<br>* SB-649868 tablets will be available with dose strength of 5 and 25 mg.<br>Drug: Zolpidem<br>* Zolpidem capsules will be available with dose strength of 10 mg.<br>* Other names: SB-649868;Drug: Placebo<br>* Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.<br>|
| Experimental: BACD sequence<br>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. | Drug: SB-649868<br>* SB-649868 tablets will be available with dose strength of 5 and 25 mg.<br>Drug: Zolpidem<br>* Zolpidem capsules will be available with dose strength of 10 mg.<br>* Other names: SB-649868;Drug: Placebo<br>* Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.<br>|
| Experimental: CBDA sequence<br>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. | Drug: SB-649868<br>* SB-649868 tablets will be available with dose strength of 5 and 25 mg.<br>Drug: Zolpidem<br>* Zolpidem capsules will be available with dose strength of 10 mg.<br>* Other names: SB-649868;Drug: Placebo<br>* Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.<br>|
| Experimental: DCAB sequence<br>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. | Drug: SB-649868<br>* SB-649868 tablets will be available with dose strength of 5 and 25 mg.<br>Drug: Zolpidem<br>* Zolpidem capsules will be available with dose strength of 10 mg.<br>* Other names: SB-649868;Drug: Placebo<br>* Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time measured overnight across four treatment sessions (4 weeks) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,