The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Casopitant oral tablets will be available with a dose of 50 milligrams.
GSK Investigational Site
Miramar, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Maximum observed concentration (Cmax) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Half-life of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Free fraction (percent unbound) of casopitant and GSK525060
Blood samples will be collected for assessment of protein binding of casopitant and GSK525060.
Time frame: 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5
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Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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 Day 22
Number of subjects with abnormal values for blood pressure
Systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Time frame: Up to Day 22
Number of subjects with abnormal values for heart rate
Heart rate will be measured.
Time frame: Up to Day 22
Number of subjects with abnormal findings after weight measurement
Weight evaluation will be performed as measure of safety.
Time frame: Up to Day 22
Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Hematology parameters will be analyzed as a measure of safety.
Time frame: Up to Day 22
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
Clinical chemistry parameters will be analyzed as a measure of safety.
Time frame: Up to Day 22
Number of subjects having abnormal values for urinalysis as a measure of safety
Urinalysis will be carried out as a measure of safety.
Time frame: Up to Day 22
Number of subjects with abnormal findings after serological tests
Serological tests will be performed as a measure of safety.
Time frame: Up to Day 22