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This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK626616, placebo, midazolam | Drug | |||
| omeprazole, caffeine, flurbiprofen, rosiglitazone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events at end of each cohort | end of each cohort | |
| hematology/chemistry/urinalysis at end of each cohort | end of each cohort | |
| physical examination at end of each cohort | end of each cohort | |
| vital signs and electrocardiogram (ECG) at end of each cohort | end of each cohort |
| Measure | Description | Time Frame |
|---|---|---|
| GSK626616 pharmacokinetics at end of each cohort | end of each cohort | |
| hemoglobin at end of each cohort | end of each cohort | |
| red blood cell measurements at end of each cohort |
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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 | Randwick, Sydney | New South Wales | 2031 | Australia | ||
| GSK Investigational Site |
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| end of each cohort |
| estimates of CYP enzyme activity at end of study | end of study |
| mRNA levels in peripheral blood at end of study | end of study |
| Herston |
| Queensland |
| 4006 |
| Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D009853 | Omeprazole |
| D002110 | Caffeine |
| D005480 | Flurbiprofen |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D001393 | Azoles |
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