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Completed

NCT Number: NCT03595202

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

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.

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Key information

Conditions

Healthy Participants

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of subjects with adverse events

    Time frame: 18 days

    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.

  2. Plasma concentrations of unchanged form (ng/mL)

    Time frame: 13 days

  3. Urinary excretions of unchanged form (ng/mL)

    Time frame: 12 days

  4. Serum EPO concentration

    Time frame: 13 days

  5. Reticulocyte count

    Time frame: 13 days

  6. Plasma vascular endothelial growth factor (VEGF) concentration

    Time frame: 13 days

  7. Serum iron (μg／dL)

    Time frame: 13 days

  8. Total iron binding capacity（μg／dL）

    Time frame: 13 days

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2018
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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