Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
- Registration Number
- NCT00358813
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects receiving casopitant Casopitant Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
- Primary Outcome Measures
Name Time Method Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060 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 Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Maximum observed concentration (Cmax) of casopitant and GSK525060 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 Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
- Secondary Outcome Measures
Name Time Method Free fraction (percent unbound) of casopitant and GSK525060 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5 Blood samples will be collected for assessment of protein binding of casopitant and GSK525060.
Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060 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 Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Half-life of casopitant and GSK525060 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 Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) Up to Day 22 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.
Number of subjects with abnormal values for blood pressure Up to Day 22 Systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Number of subjects with abnormal values for heart rate Up to Day 22 Heart rate will be measured.
Number of subjects with abnormal findings after weight measurement Up to Day 22 Weight evaluation will be performed as measure of safety.
Number of subjects having abnormal hematology laboratory parameters as a measure of safety Up to Day 22 Hematology parameters will be analyzed as a measure of safety.
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety Up to Day 22 Clinical chemistry parameters will be analyzed as a measure of safety.
Number of subjects having abnormal values for urinalysis as a measure of safety Up to Day 22 Urinalysis will be carried out as a measure of safety.
Number of subjects with abnormal findings after serological tests Up to Day 22 Serological tests will be performed as a measure of safety.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Minneapolis, Minnesota, United States