Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00404378 | Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769] | PHASE1 | COMPLETED | 15 | — | — | Oct 20, 2006 | Jan 5, 2007 | Sep 12, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Inclusion Criteria: * Healthy male or females * Females must be of non-childbearing potential * Adequate organ functions * Able to swallow and retain oral medications * Able to understand and comply with study requirements * Signed ICF Exclusion Criteria: * Clinically relevant abnormality identif...