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

NCT03591133 | Completed Phase 1

• 1 other identifier: TS143-01-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  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.

  8 days

• Plasma concentrations of unchanged form (ng/mL)

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

  72 hours

• Urinary excretions of unchanged form (ng/mL)

  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.

  72 hours

• Serum erythropoietin (EPO) concentration

  72 hours

Study Arms (6)

Step1:3㎎ QD

OTHER

Drug: TS-143 3mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Step2:6㎎ QD

OTHER

Drug: TS-143 6mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Step3-1:11㎎ QD

OTHER

Drug: TS-143 11mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Step3-2:11㎎ QD（Fed)

OTHER

Drug: TS-143 11mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Step4:20㎎ QD

OTHER

Drug: TS-143 20mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Step5:36㎎ QD

OTHER

Drug: TS-143 36mg Drug: Placebo

Drug: TS-143; Drug: Placebo

Interventions

TS-143 DRUG

Step1:3㎎ QD; Step2:6㎎ QD; Step3-1:11㎎ QD; Step3-2:11㎎ QD（Fed); Step4:20㎎ QD; Step5:36㎎ QD

Placebo DRUG

Step1:3㎎ QD; Step2:6㎎ QD; Step3-1:11㎎ QD; Step3-2:11㎎ QD（Fed); Step4:20㎎ QD; Step5:36㎎ QD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Related Publications (1)

• Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.

  PMID: 30176654 BACKGROUND

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 19, 2018
• Study Start: December 24, 2015
• Primary Completion: April 14, 2016
• Study Completion: April 14, 2016
• Last Updated: February 28, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)