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The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.
The purpose of this study is to evaluate to determine the effect of food on the PK( pharmacokinetics) of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects and to assess the safety and tolerability of single doses of 600mg in healthy subjects.This study will be an open-label, randomized, four-period, crossover PK food effect study of Volitinib administered orally at 600 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 4 treatments,2 weeks follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volitinib ,after high fat meal intake | Experimental | A:single oral Volitinib after high fat meal intake |
|
| Volitinib,after general diet | Experimental | B:single oral Volitinib, after general diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volitinib | Drug | 600mg Volitinib ,single dose,oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | The following PK parameters will be derived from the plasma concentration-time profile of Volitinib following administration:Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);Apparent oral Clearance (CL/F);Apparent oral Volume of distribution (Vz/F);Other parameters, such as elimination half-life | 1-3days after every drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | AE(adverse event) will be summarized by type and severity | 1 day to the 14days after every drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Urinal and fecal excretion ratio of Volitnib;renal clearance of Volitinib | Urinal and fecal excretion ratio of Volitnib, renal clearance of Volitinib;Preliminary metabolite profiling of Volitnib in healthy subjects, with preliminary understanding of the clearance mechanism of Volitinib in human | duriation the first day to the third day after every drug administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen yu | Xuhui Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| C000593259 | 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine |
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