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To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step1:3㎎ QD | Other | Drug: TS-143 3mg Drug: Placebo |
|
| Step2:6㎎ QD | Other | Drug: TS-143 6mg Drug: Placebo |
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| Step3-1:11㎎ QD | Other | Drug: TS-143 11mg Drug: Placebo |
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| Step3-2:11㎎ QD(Fed) | Other | Drug: TS-143 11mg Drug: Placebo |
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| Step4:20㎎ QD | Other | Drug: TS-143 20mg Drug: Placebo |
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| Step5:36㎎ QD | Other | Drug: TS-143 36mg Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-143 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | To evaluate the safety of TS-143 given single administration in healthy volunteers by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters. | 8 days |
| Plasma concentrations of unchanged form (ng/mL) | The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing. | 72 hours |
| Urinary excretions of unchanged form (ng/mL) | The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group. | 72 hours |
| Serum erythropoietin (EPO) concentration | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment
Subjects who meet any of the following criteria in the screening tests
Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30176654 | Result | Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3. |
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| Placebo | Drug |
|