Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: TS-143
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted prior to the investigational drug treatment 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 Red blood cell count: ≥ 535 × 10^4 /μL Hemoglobin: ≥ 16.2 g/dL Hematocrit: ≥ 47.5% Reticulocyte ratio: Outside of the reference value range Subjects who meet any of the following criteria in the screening tests Serum EPO concentration: Outside of the reference value range Ferritin: 30 ng/mL or less, or ≥ 262 ng/mL 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 Blood pressure: Systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg or more Pulse rate: < 40 bpm, or ≥ 100 bpm Body temperature: ≥ 37.5°C

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Step1:3㎎ QD<br>Drug: TS-143 3mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |
| Other: Step2:6㎎ QD<br>Drug: TS-143 6mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |
| Other: Step3-1:11㎎ QD<br>Drug: TS-143 11mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |
| Other: Step3-2:11㎎ QD（Fed)<br>Drug: TS-143 11mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |
| Other: Step4:20㎎ QD<br>Drug: TS-143 20mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |
| Other: Step5:36㎎ QD<br>Drug: TS-143 36mg Drug: Placebo | Drug: TS-143<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |