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This is an open-label, randomized, single-dose, single-center, parallel-group bioequivalence study of orally- and IV-administered rolapitant in healthy male and female subjects.
To assess the bioequivalence of a single oral dose of 200 mg rolapitant and a single intravenous dose of 185 mg rolapitant administered as an infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rolapitant - Oral | Experimental | Investigational Product: Rolapitant Dose: 200 mg (4 x 50mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) |
|
| Rolapitant - IV | Experimental | Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rolapitant - Oral | Drug | Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration | 39-69 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: observed maximum plasma concentration | 39-69 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax: observed time to reach Cmax | 39-69 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Vargo, MD | Tesaro, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel | Baltimore | Maryland | 21225 | United States |
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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 |
|---|---|
| C578834 | rolapitant |
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| Rolapitant - IV | Drug | IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight) |
|
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