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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving casopitant | Experimental | Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casopitant | Drug | Casopitant oral tablets will be available with a dose of 50 milligrams. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miramar | Florida | 33025 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study NKT102783 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKT102783 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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| Half-life of casopitant and GSK525060 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis. | 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. | 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5 |
| 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. | Up to Day 22 |
| Number of subjects with abnormal values for blood pressure | Systolic (SBP) and diastolic blood pressure (DBP) will be measured. | Up to Day 22 |
| Number of subjects with abnormal values for heart rate | Heart rate will be measured. | Up to Day 22 |
| Number of subjects with abnormal findings after weight measurement | Weight evaluation will be performed as measure of safety. | 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. | 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. | 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. | Up to Day 22 |
| Number of subjects with abnormal findings after serological tests | Serological tests will be performed as a measure of safety. | Up to Day 22 |
| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102783 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |