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This study is being conducted to measure the amount of study drug that is in your blood after you receive a different type of tablet in each of four study visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW856553 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 1) to demonstrate bioequivalence of four different particle sizes by assay of blood from dosing through 72 hours post dose in each of four study periods |
| Measure | Description | Time Frame |
|---|---|---|
| 1) determine/compare relative bioavailability by assay of blood (dosing to 72 hr in 4 study periods) 2) assess safety/tolerability of single oral doses thru AE reporting; vs & ECG monitoring from per 1 dosing thru study f/u | ||
| determine the relative bioavailability of a single oral dose of 15 mg GW856553 in healthy subjects using a tablet with a particle size of > 20 microns (a milled formulation) compared to tablets with particle sizes of 2 microns, 4 microns, and 6 microns. |
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Inclusion Criteria:
Healthy adult males and females between 18 and 60 years of age, inclusive. Whether a subject is "healthy" will be determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
To be eligible, female subjects must have a negative pregnancy test (i.e. serum hCG test) and be of:
Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptive, inject able progesterone, or sub dermal implant if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until completion of follow up procedures.
Body weight >/ 50 kg (110 pounds) for men and >/ 45 kg (99 pounds) for women and body mass index (BMI) between 19 and 31.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within reference range at screening.
Signed and dated written informed consent prior to admission to the study. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tacoma | Washington | 98418 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001172 | Arthritis, Rheumatoid |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C543534 | 6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |