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Completed

NCT Number: NCT03591133

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

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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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 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

Treatment and study plan

TS-143

Drug

Placebo

Drug

Primary outcomes

  1. Incidence of adverse events

    Time frame: 8 days

    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.

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

    Time frame: 72 hours

    The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.

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

    Time frame: 72 hours

    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.

  4. Serum erythropoietin (EPO) concentration

    Time frame: 72 hours

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 (Single-Dose Administration)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 19, 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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