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

NCT03595202 | Completed Phase 1

• 1 other identifier: TS143-01-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Step1:4㎎ TID

OTHER

TS-143 12mg total dose/day or Placebo

Drug: TS-143; Drug: Placebo

Step2:11㎎ TID

OTHER

TS-143 33mg total dose/day or Placebo

Drug: TS-143; Drug: Placebo

Interventions

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.

Step1:4㎎ TID; Step2:11㎎ TID

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.

Step1:4㎎ TID; Step2:11㎎ TID

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Study Officials

• Shigeru Okuyama

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: July 23, 2018
• Study Start: April 3, 2017
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: February 28, 2025

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)