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The purpose of the study is to evaluate how subjects with mild or moderate liver 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 |
|---|---|---|---|
| Healthy subjects receiving GW679769 | Experimental | Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days. |
|
| Subjects with hepatic impairment receiving GW679769 | Experimental | Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug | GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects | Blood samples for pharmacokinetics (PK) analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| AUC of multiple oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed concentration (tmax) of single oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
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 | Gainesville | Florida | 32608 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study NKT102785 can be found on the GSK Clinical Study Register. | View source |
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKT102785 | 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 |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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| Cmax of multiple oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| AUC of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| AUC of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Cmax of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| Cmax of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| tmax of multiple oral dose of GW679769 in healthy subjects |
Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data. |
| Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| tmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| tmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| tmax of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| tmax of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| tmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| tmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. tmax will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Terminal half-life (t1/2) of single oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| t1/2 of multiple oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| t1/2 of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| t1/2 of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GW679769 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| t1/2 of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| t1/2 of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| t1/2 of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours |
| t1/2 of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. t1/2 will be calculated from plasma GSK525060 concentration-time data | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours |
| Percentage of unbound GW679769 in healthy subjects receiving single oral dose of GW679769 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1 |
| Percentage of unbound GW679769 in healthy subjects receiving multiple oral dose of GW679769 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data | 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose |
| Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving single oral dose of GW679769 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1 |
| Percentage of unbound GW679769 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GW679769 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GW679769 will be calculated from plasma GW679769 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose |
| Percentage of unbound GSK525060 in healthy subjects receiving single oral dose of GSK525060 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1 |
| Percentage of unbound GSK525060 in healthy subjects receiving multiple oral dose of GSK525060 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose |
| Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving single oral dose of GSK525060 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1 |
| Percentage of unbound GSK525060 in subjects with mild and moderate hepatic impairment receiving multiple oral dose of GSK525060 | Blood samples for PK analysis will be collected at the indicated time points. Percentage of unbound GSK525060 will be calculated from plasma GSK525060 concentration-time data. | 1, 2, 4 and 24 hours post-dose on Day 1. Day 5, Pre-dose, 1, 2, 4, 24 hours post-dose |
| Number of subjects with Adverse events (AE) and Serious AEs (SAE) | An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent disability/incapacity, or may led to any congenital anomaly or birth defect | Up to Day 22 |
| Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Blood pressure measurement will be assessed in supine and resting position. | Up to Day 22 |
| Number of subjects with abnormal heart rate | Blood pressure measurement will be assessed in supine and resting position. | Up to Day 22 |
| Number of subjects with abnormal hematology parameters | Laboratory assessment for hematology parameters will include hemoglobin, hematocrit, red blood cell count (RBC), platelet count, white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, prothrombin time (PT), and International Normalized Ratio (INR) | Up to Day 22 |
| Number of subjects with abnormal clinical chemistry parameters | Laboratory assessment for clinical chemistry parameters sodium, potassium, chloride, total Carbon dioxide, calcium, glucose (fasting), phosphorous (inorganic), protein (total), albumin, gamma-glutamyl-transferase (GGT), bilirubin (total), alkaline Phosphatase, lactic dehydrogenase (LDH), aspartate aminotransferase (AST; Serum glutamic oxaloacetic transaminase), alanine aminotransferase (ALT; Serum glutamic pyruvic transaminase), creatinine, blood Urea Nitrogen, uric Acid, creatine Phosphokinase (CPK), and ammonia | Up to Day 22 |
| Number of subjects with abnormal urinalysis | Laboratory assessment for urinalysis parameters pH, specific gravity, glucose, protein, ketones, and blood | Up to Day 22 |
| Orlando |
| Florida |
| 32809 |
| United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKT102785 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |