Disturbed Sleep Model Study.

NCT00440323 | Completed Phase 1

• 1 other identifier: OXS104094
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (4)

ADBC sequence

EXPERIMENTAL

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; Drug: Zolpidem; Drug: Placebo

BACD sequence

EXPERIMENTAL

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; Drug: Zolpidem; Drug: Placebo

CBDA sequence

EXPERIMENTAL

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; Drug: Zolpidem; Drug: Placebo

DCAB sequence

EXPERIMENTAL

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; Drug: Zolpidem; Drug: Placebo

Interventions

SB-649868 DRUG

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

ADBC sequence; BACD sequence; CBDA sequence; DCAB sequence

Zolpidem DRUG

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

Also known as: SB-649868

ADBC sequence; BACD sequence; CBDA sequence; DCAB sequence

Placebo DRUG

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

ADBC sequence; BACD sequence; CBDA sequence; DCAB sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Guildford, Surrey, GU2 7XP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22237311 DERIVED

Related Links

• Results for study OXS104094 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: January 5, 2007
• Primary Completion: July 3, 2007
• Study Completion: July 3, 2007
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

GB (1)