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This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of [14C]-GSK706769 alone and in the presence of Ketoconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-GSK706769 | Experimental | Single dose of 50µg [14C]-GSK706769 containing 250 nCi |
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| [14C]-GSK706769 + Ketoconazole | Experimental | An oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg [14C]-GSK706769 containing 250 nCi on day 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-GSK706769 | Drug | 50µg [14C]-GSK706769 containing 250 nCi |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Tmax, AUC0-t. AUC0-infinity, total plasma clearance (CL/F), apparent volume of distribution (V/F) and terminal phase half-life (t1/2) will also be calculated where data permit. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety and tolerability data including spontaneous Adverse Event reporting, ECGs, vital signs, nursing/physician observation, physical examination and clinical laboratory values. | Throughout study |
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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 | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Results for study 113191 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole | Drug | 200 mg Ketoconazole (Q12) |
|