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

NCT ID: NCT03595202

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2017-07-07

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Step1:4㎎ TID

TS-143 12mg total dose/day or Placebo

Group Type: OTHER

TS-143

Intervention Type: 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.

Placebo

Intervention Type: 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.

Step2:11㎎ TID

TS-143 33mg total dose/day or Placebo

Group Type: OTHER

TS-143

Intervention Type: 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.

Placebo

Intervention Type: 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.

Interventions

TS-143

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with a 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 before the investigational drug treatment on Day 1
• Subjects capable of receiving an explanation of this study before participation, understanding the details, and providing written informed consent themselves

Exclusion Criteria

1. 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:

• Red blood cell count: ≥535 × 10^4 /μL
• Hemoglobin: ≥16.2 g/dL
• Hematocrit: ≥47.5%
• Reticulocyte rate: Outside of the reference value range

2. Subjects meeting any of the following criteria in the screening tests:

• Serum EPO concentration: Outside of the reference value range
• Ferritin: ≤30 ng/mL or >upper limit of the reference value

3. 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:

• Blood pressure: Systolic blood pressure ≥140 mmHg, or diastolic blood pressure ≥90 mmHg
• 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

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shigeru Okuyama

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS143-01-03

Identifier Type: -

Identifier Source: org_study_id