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This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment | Experimental | Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142 |
|
| Moderate hepatic impairment | Experimental | Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142 |
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| Normal hepatic function | Experimental | Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 5 mg | Drug | Single-dose of 5 mg of TS-142 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration | Plasma concentration of unchanged form and its metabolite | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Maximum plasma concentration of unchanged form and its metabolite (Cmax) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Time to maximum plasma concentration of unchanged form and its metabolite (tmax) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Terminal elimination rate constant of unchanged form and its metabolite (λz) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Elimination half-life of unchanged form and its metabolite (t1/2) | Predose and up to 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | "Adverse event" refers to any unfavorable or unintended disease or symptom thereof (including abnormal laboratory tests values) occurring in a subject who has been administered an investigational product, whether or not there is a causal relationship with the investigational product. | From administration of investigational product through 10 days after administration of investigational product |
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Inclusion Criteria:
<Inclusion criteria for patients with hepatic impairment>
<Inclusion criteria for subject with normal hepatic function>
Exclusion Criteria:
<Exclusion criteria for patients with hepatic impairment>
<Exclusion criteria for subjects with normal hepatic function>
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
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| Pharmacokinetic parameters |
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F) |
| Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Apparent total body clearance of unchanged form (CL/F) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Plasma unbound fraction of unchanged form and its metabolite (fu) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound)) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Area under the plasma concentration-time curve extrapolated to infinity adjusted by unbound fraction of unchanged form (AUC(unbound)) | Predose and up to 48 hours postdose |
| Pharmacokinetic parameters | Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F) | Predose and up to 48 hours postdose |