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This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Treatment Period 1 | Experimental | Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days. |
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| Cohort 1 Treatment Period 2 | Experimental | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole. |
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| Cohort 2 Treatment Period 1 | Experimental | Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days. |
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| Cohort 2 Treatment Period 2 | Experimental | Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoconazole | Drug | Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3. | Period 1: Day 1, 2 & 3 | |
| Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8. | Period 2: Day 4, 5, 6, 7, & 8. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests | throughout the study |
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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 | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| Results for study NKV105093 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 |
|---|---|---|---|
| NKV105093 | Dataset Specification | 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 |
|---|---|
| D009325 | Nausea |
| 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 |
|---|---|
| D007654 | Ketoconazole |
| C531951 | casopitant |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| casopitant 100 mg | Drug | Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time |
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| Casopitant 50 mg | Drug | Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time. |
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For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105093 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |