InsomniaPhase 1NCT00534872
A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population
A Phase 1 study testing SB-649868 in people with Insomnia, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- SB-649868
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult and elderly female and male
- Female must be of non-childbearing potential
- Body weight =50 kg
Who cannot join
- Abuse of alcohol or drugs
- Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
- Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication
- Smoking history of = 10 cigarettes a day in the last three months
- History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases
- Participation in clinical trial during the previous 6 months
About this study
Official title: A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female "Non-childbearing Potential", Healthy Male and in Healthy Elderly Subjects
The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population
- Conditions
- Insomnia
- Being tested
- SB-649868
- Keywords
- 4 Parallel cohorts, Healthy Female, Healthy Elderly, Pharmacokinetic, Safety and Tolerability
- 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
10 mg
| Study group | Role | What they receive |
|---|---|---|
| SB649868 | Experimental | 10 mg Receives: Drug: SB-649868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Measured: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary outcomes (1)
Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868
Measured: within 7-14 days from a single dose of SB-649868
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2007 (estimated)
- Study completionOct 2007 (estimated)
Why it stopped: The study was stoppend before recruitment start for preclinical safety finding in rats.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534872
- Sponsor's protocol ID
- OXS109143
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2007
- Last updated
- 17 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female "Non-childbearing Potential", Healthy Male and in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT00534872
- Acronym / sponsor ID
- OXS109143
- Conditions
- Insomnia
- Keywords
- 4 Parallel cohorts, Healthy Female, Healthy Elderly, Pharmacokinetic, Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stoppend before recruitment start for preclinical safety finding in rats.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (estimated)
- Study completion
- Oct 2007 (estimated)
- First posted
- 26 Sep 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.
The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB649868 | Experimental | Drug: SB-64986810 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult and elderly female and male
- Female must be of non-childbearing potential
- Body weight =50 kg
Key exclusion criteria (6 listed)
- Abuse of alcohol or drugs
- Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
- Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication
- Smoking history of = 10 cigarettes a day in the last three months
- History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases
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-64986810 mg | Drug | SB649868 |
Primary outcome
Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Time frame: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
1 secondary outcome
Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868
Time frame: within 7-14 days from a single dose of SB-649868
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB-649868 in people with Insomnia, run by GlaxoSmithKline.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours (time frame: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015.