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To investigate the safety, pharmacokinetics and pharmacodynamics of TS-143 when administered 3 times a day for 10 days to healthy Japanese adult males using placebo-controlled, double-blind, dose escalation study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step1:4㎎ TID | Other | TS-143 12mg total dose/day or Placebo |
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| Step2:11㎎ TID | Other | TS-143 33mg total dose/day or Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-143 | Drug | Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subjects with adverse events | To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of subjects with adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters. | 18 days |
| Plasma concentrations of unchanged form (ng/mL) | 13 days | |
| Urinary excretions of unchanged form (ng/mL) | 12 days | |
| Serum EPO concentration | 13 days | |
| Reticulocyte count | 13 days | |
| Plasma vascular endothelial growth factor (VEGF) concentration | 13 days | |
| Serum iron (μg/dL) | 13 days | |
| Total iron binding capacity(μg/dL) | 13 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria in the results of screening tests, tests conducted on the day before the first investigational treatment (Day -1), and tests conducted before the investigational drug treatment on the morning of Day 1:
Subjects meeting any of the following criteria in the screening tests:
Subjects meeting any of the following criteria in the vital signs in the screening tests and the tests conducted before the investigational drug treatment on the morning of Day 1:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Okuyama | 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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| Placebo | Drug | Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2. |
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