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GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects in Cohort-1 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 10 mg or Placebo. |
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| Subjects in Cohort-2 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. |
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| Subjects in Cohort-3 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. |
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| Subjects in Cohort-4 of Section 1 | Experimental | Subjects will be randomized to receive either GSK598809 40 mg or Placebo. |
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| Subjects in Cohort-5 of Section 2 | Experimental | Subjects will be randomized to receive either ascending doses of GSK598809 75, 120 and 175 mg or Placebo. There will be a washout period of 6 days between the doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK598809 | Drug | GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose | Up to Day 39 |
| Measure | Description | Time Frame |
|---|---|---|
| Tests on cognition (thinking) for 24 hours after dosing | Up to Day 36 | |
| Akathisia assessment | Up to Day 36 | |
| Involuntary Movements |
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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 DAN106587 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000594007 | GSK598809 |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Subjects in Cohort-6 of Section 3 | Experimental | Subjects will receive caffeine on day -1 and after randomization subject will either receive GSK598809 or Placebo on Day 1. After washout period of 1-week subject will either receive GSK598809 or Placebo for 28 days. |
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| Placebo | Drug | Subjects will receive matching placebo capsules to GSK598809 orally with water. |
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| Caffeine | Drug | Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered. |
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| Up to Day 36 |
| Simpson Angus Scale (SAS) | Up to Day 36 |
| Serum prolactin, GH and thyroid stimulating hormone (TSH), total and free testosterone, LH and FSH concentrations as possible | Up to Day 39 |
| Psychological assessment | Up to Day 36 |
| Cognition/impulsivity: | Up to Day 35 |
| Pharmacokinetics: | Up to Day 38 |
| GSK685249 levels to derive pharmacokinetic parameter | Up to Day 38 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |