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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-24

Study Completion Date

2016-04-14

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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Step1:3㎎ QD

Drug: TS-143 3mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Step2:6㎎ QD

Drug: TS-143 6mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Step3-1:11㎎ QD

Drug: TS-143 11mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Step3-2:11㎎ QD（Fed)

Drug: TS-143 11mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Step4:20㎎ QD

Drug: TS-143 20mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Step5:36㎎ QD

Drug: TS-143 36mg Drug: Placebo

Group Type OTHER

TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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TS-143

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
2. 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

1. 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
2. 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
3. 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes