Disturbed Sleep Model Study.

August 15, 2017 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XP
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: 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.
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.
Other Names:
  • SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: 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.
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.
Other Names:
  • SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Experimental: 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.
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.
Other Names:
  • SB-649868
Drug: Placebo
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2007

Primary Completion (Actual)

July 3, 2007

Study Completion (Actual)

July 3, 2007

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXS104094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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