Sleep Initiation and Maintenance DisordersPhase 1NCT00440323
Disturbed Sleep Model Study.
A Phase 1 study testing SB-649868 and Zolpidem in people with Sleep Initiation and Maintenance Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- SB-649868 and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2007to 3 Jul 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Guildford, Surrey, GU2 7XP
About this study
Official title: 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.
- Being tested
- SB-649868, Zolpidem, Placebo
- Keywords
- Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-649868Drug
SB-649868 tablets will be available with dose strength of 5 and 25 mg.
ZolpidemDrug
Also called SB-649868
Zolpidem capsules will be available with dose strength of 10 mg.
PlaceboDrug
Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: SB-649868; Drug: Zolpidem; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Measured: 4 weeks
Secondary outcomes (1)
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study start5 Jan 2007
- Primary completion3 Jul 2007
- Study completion3 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440323
- Sponsor's protocol ID
- OXS104094
- Status last verified
- Aug 2017
- First submitted
- 23 Feb 2007
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22237311
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00440323
- Acronym / sponsor ID
- OXS104094
- Keywords
- Noise induced Situational insomnia,, healthy volunteers, SB-649868,, Zolpidem,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2007 (actual)
- Primary completion
- 3 Jul 2007 (actual)
- Study completion
- 3 Jul 2007 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADBC sequence | Experimental | Drug: SB-649868, Drug: Zolpidem, Drug: PlaceboIn 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. |
| BACD sequence | Experimental | Drug: SB-649868, Drug: Zolpidem, Drug: PlaceboIn 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. |
| CBDA sequence | Experimental | Drug: SB-649868, Drug: Zolpidem, Drug: PlaceboIn 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. |
| DCAB sequence | Experimental | Drug: SB-649868, Drug: Zolpidem, Drug: PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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".
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-649868SB-649868 tablets will be available with dose strength of 5 and 25 mg. | Drug | ADBC sequence, BACD sequence, CBDA sequence, DCAB sequence |
| ZolpidemAlso: SB-649868Zolpidem capsules will be available with dose strength of 10 mg. | Drug | ADBC sequence, BACD sequence, CBDA sequence, DCAB sequence |
| PlaceboPlacebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available. | Drug | ADBC sequence, BACD sequence, CBDA sequence, DCAB sequence |
Primary outcome
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Time frame: 4 weeks
1 secondary outcome
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Derived from this study: PubMed 22237311Bettica 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.
- Results for study OXS104094 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB-649868 and Zolpidem in people with Sleep Initiation and Maintenance Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time measured overnight across four treatment sessions (4 weeks) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.