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This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1605786 250mg | Experimental | Opaque Swedish orange body and cap. |
|
| Placebo | Placebo Comparator | Opaque Swedish orange body and cap. |
|
| GSK1605786 500mg | Experimental | Opaque Swedish orange body and cap. |
|
| GSK1605786 1000mg | Experimental | Opaque Swedish orange body and cap. |
|
| GSK1605786 500mg in fed | Experimental | Opaque Swedish orange body and cap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1605786 | Drug | Opaque Swedish orange body and cap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration | up to 72h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse envents | up to 72h post dose | |
| Vital signe | up to 72h post dose | |
| Clinical laboratory |
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Inclusion Criteria:
Exclusion Criteria:
- Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia |
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| Label | URL |
|---|---|
| Results for study 114472 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| GSK1605786 Placebo | Drug | Opaque Swedish orange body and cap. |
|
| up to 72h post dose |
| 12 lead ECG | up to 72h post dose |
| D007410 | Intestinal Diseases |