Trials / Completed
CompletedNCT00440323
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SB-649868 | SB-649868 tablets will be available with dose strength of 5 and 25 mg. |
| DRUG | Zolpidem | Zolpidem capsules will be available with dose strength of 10 mg. |
| DRUG | Placebo | Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available. |
Timeline
- Start date
- 2007-01-05
- Primary completion
- 2007-07-03
- Completion
- 2007-07-03
- First posted
- 2007-02-27
- Last updated
- 2017-08-17
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00440323. Inclusion in this directory is not an endorsement.