GSK Investigational Site
Edinburgh, EH33 2NE, United Kingdom
NCT Number: NCT00599612
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.
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Notify Me30 year–60 year
Male
Interventional
Phase 1
Edinburgh, EH33 2NE, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 10 days
The urinary and fecal cumulative excretion will be analyzed.
Time frame: 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
Blood samples will be collected at specific time points for calculating AUC (0-inf)
Time frame: 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
Blood samples will be collected at specific time points for calculating Cmax
Time frame: 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
Blood samples will be collected at specific time points for calculating AUC(0-t)
Time frame: 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
Blood samples will be collected at specific time points for calculating Tmax
Time frame: 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
Blood samples will be collected at specific time points for calculating T1/2
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples will be collected at specific time points for calculating AUC(0-inf)
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-inf)
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples will be collected at specific time points for calculating Cmax
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples for metabolite analysis will be collected at specific time points for calculating Cmax
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples will be collected at specific time points for calculating AUC(0-t)
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-t)
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples will be collected at specific time points for calculating Tmax
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples for metabolite analysis will be collected at specific time points for calculating Tmax
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples will be collected at specific time points for calculating T1/2
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Blood samples for metabolite analysis will be collected at specific time points for calculating T1/2
Time frame: Up to 15 days
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.
Time frame: Up to 15 days
Full 12-lead ECGs will be recorded using an ECG machine
Time frame: Up to 15 days
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.
Time frame: Up to 15 days
Heart rate values will be measured in a supine position having rested in this position for at least 10 minutes before each reading.
Time frame: Up to 15 days
Samples for clinical chemistry tests will be collected as a measure of safety
Time frame: Up to 15 days
Samples for clinical hematology tests will be collected as a measure of safety
Time frame: Up to 15 days
Urine samples for urine analysis tests will be collected as a measure of safety
Time frame: Up to 15 days
Samples for liver function tests will be collected as a measure of safety
GlaxoSmithKline
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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