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This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan |
|
| Cohort 2 | Other | Subjects will be receive GSK1034702 5 mg following the dose escalation plan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1034702 | Drug | Oral or liquid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| •Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Bond-Lader Visual Analogue Scale. | 20 weeks | |
| Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone. | 20 weeks | |
| Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7NS | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 110623 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| C568644 | GSK 1034702 |
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| Drug |
To match GSK1034702 |
|
| 20 weeks |