Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine and fecal samples will be collected until 216 hour after dosing but subjects may be discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 hour period. Blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. Samples of urine, faeces and plasma will be transferred into a separate study to characterize and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram (ECG) and clinical laboratory tests.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy male volunteers | Experimental | Six healthy male volunteers aged between 30-60 years old will be recruited for this study, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW856553 | Drug | A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the total radioactive dose administered over time | The urinary and fecal cumulative excretion will be analyzed. | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) from time zero to infinity (AUC[0-inf]) of total drug | Blood samples will be collected at specific time points for calculating AUC (0-inf) | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose |
| Maximum plasma concentration(Cmax) of total drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edinburgh | EH33 2NE | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C543534 | 6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples will be collected at specific time points for calculating Cmax |
| Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose |
| AUC from zero to the time of the last measurable concentration (AUC[0-t]) of total drug | Blood samples will be collected at specific time points for calculating AUC(0-t) | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose |
| First time of occurrence of maximum observed concentration (Tmax) of total drug | Blood samples will be collected at specific time points for calculating Tmax | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose |
| Terminal plasma half-life (t1/2) of total drug | Blood samples will be collected at specific time points for calculating T1/2 | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose |
| AUC(0-inf) of GW856553 | Blood samples will be collected at specific time points for calculating AUC(0-inf) | Pre-dose and 1, 4, 12 hours post-dose |
| AUC(0-inf) of GSK198602 | Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-inf) | Pre-dose and 1, 4, 12 hours post-dose |
| Cmax of GW856553 | Blood samples will be collected at specific time points for calculating Cmax | Pre-dose and 1, 4, 12 hours post-dose |
| Cmax of GSK198602 | Blood samples for metabolite analysis will be collected at specific time points for calculating Cmax | Pre-dose and 1, 4, 12 hours post-dose |
| AUC(0-t) of GW856553 | Blood samples will be collected at specific time points for calculating AUC(0-t) | Pre-dose and 1, 4, 12 hours post-dose |
| AUC(0-t) of GSK198602 | Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-t) | Pre-dose and 1, 4, 12 hours post-dose |
| Tmax of GW856553 | Blood samples will be collected at specific time points for calculating Tmax | Pre-dose and 1, 4, 12 hours post-dose |
| Tmax of GSK198602 | Blood samples for metabolite analysis will be collected at specific time points for calculating Tmax | Pre-dose and 1, 4, 12 hours post-dose |
| T1/2 of GW856553 | Blood samples will be collected at specific time points for calculating T1/2 | Pre-dose and 1, 4, 12 hours post-dose |
| T1/2 of GSK198602 | Blood samples for metabolite analysis will be collected at specific time points for calculating T1/2 | Pre-dose and 1, 4, 12 hours post-dose |
| Number of subjects with Adverse events (AEs) and serious adverse events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. | Up to 15 days |
| Number of subjects with abnormal ECG findings | Full 12-lead ECGs will be recorded using an ECG machine | Up to 15 days |
| Number of subjects with abnormal blood pressure values | Systolic and diastolic blood pressure values will be measured in a supine position having rested in this position for at least 10 minutes before each reading. | Up to 15 days |
| Number of subjects with abnormal heart rate values | Heart rate values will be measured in a supine position having rested in this position for at least 10 minutes before each reading. | Up to 15 days |
| Number of subjects with abnormal clinical chemistry parameters | Samples for clinical chemistry tests will be collected as a measure of safety | Up to 15 days |
| Number of subjects with abnormal clinical hematology parameters | Samples for clinical hematology tests will be collected as a measure of safety | Up to 15 days |
| Number of subjects with abnormal urine analysis parameters | Urine samples for urine analysis tests will be collected as a measure of safety | Up to 15 days |
| Number of subjects with abnormal liver function tests | Samples for liver function tests will be collected as a measure of safety | Up to 15 days |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |