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Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | All subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2. |
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| Cohort 2, Group A | Placebo Comparator | Subjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2. |
|
| Cohort 2, Group B | Experimental | In treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casopitant 150 mg | Drug | Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1. | Day 4 to 9 in Cohort 1. | |
| Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and | Day 2 to 4 of Period 1 | |
| casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2. | Day 4 to 9 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety is evaluated in Cohort 1 by: - Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU) | at Screen, Day -1 & Followup (FU) | |
| - Vitals Signs monitored at Screen, Day -1, 4-7 and FU | at Screen, Day -1, 4-7 and FU |
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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 | Overland Park | Kansas | 66211 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20124517 | Background | Johnson BM, Adams LM, Zhang K, Gainer SD, Kirby LC, Blum RA, Apseloff G, Morrison RA, Schutz RA, Lebowitz PF. Ketoconazole and rifampin significantly affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1 receptor antagonist. J Clin Pharmacol. 2010 Aug;50(8):951-9. doi: 10.1177/0091270009353761. Epub 2010 Feb 2. |
| Label | URL |
|---|---|
| Results for study 109990 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKV109990 | Statistical Analysis Plan | 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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| Ketoconazole | Drug | Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days). |
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| Casopitant 150 mg matching placebo | Drug | Casopitant 150 mg matching placebo will be available as white, film-coated tablets. |
|
| Casopitant 50 mg | Drug | Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach. |
|
| Casopitant 50 mg matching placebo | Drug | Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets. |
|
| - 12 lead ECGs at Screen & FU | at Screen & FU |
| - Adverse Events Monitoring starting at Day 1 | Day 1 |
| Buffalo |
| New York |
| 14202 |
| United States |
| GSK Investigational Site | Columbus | Ohio | 43212 | United States |
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV109990 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 |
|---|---|
| C531951 | casopitant |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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