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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00440323

Enrollment

Registered

2007-02-27

Start date

2007-01-05

Completion date

2007-07-03

Last updated

2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,

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.

Interventions

DRUGSB-649868

SB-649868 tablets will be available with dose strength of 5 and 25 mg.

DRUGZolpidem

Zolpidem capsules will be available with dose strength of 10 mg.

DRUGPlacebo

Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Total Sleep Time measured overnight across four treatment sessions (4 weeks)	4 weeks

Secondary

Measure	Time frame
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)	4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026