To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]GW856553 in Healthy Adult Males
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 mg oral dose of GW856553 containing 50 microCi of [14C] GW856553. Urine and faecal samples will be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 h 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 characterise and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, ECG and clinical laboratory tests.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Determine the Safety, Tolerability, Excretion Balance and Pharmacokinetics of [14C]GW856553, Administered as a Single Dose of an Oral Solution to Healthy Adult Male Subjects.|
- Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection, for approximately 10 days (or longer) of plasma, urine and fecal samples for assessment of parent and metabolites. [ Time Frame: approximately 10 days ]
- Clinical Safety data. PK parameters of GW856553 and drug-related material (radioactivity) in plasma urine and faeces following oral dosing. Samples are collected for approximately 10 days (or longer) following oral dosing. [ Time Frame: approximately 10 days ]
- AUC(0-inf), Cmax, AUC(0-t), tmax and t½ of total drug-related material (radioactivity) in plasma following oral dosing.
- AUC(0-inf), Cmax, AUC(0-t), tmax, t½ of GW856553 and its major metabolite GSK198602 in plasma following oral dosing.
- Adverse events, ECG, vital signs and clinical laboratory tests (including LFTs).
- Characterisation and quantification of metabolites in plasma, urine and faecal homogenates will be performed under a separate protocol by Drug Metabolism and Pharmacokinetics (DMPK), GSK and results will be reported in a separate report.
|Study Start Date:||January 2008|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599612
|GSK Investigational Site|
|Edinburgh, United Kingdom, EH33 2NE|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|