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

Phase I 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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: TS-143

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
2. 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:

1. 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

2. 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

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Step1:3㎎ QD; Drug: TS-143 3mg Drug: Placebo	Drug: Placebo; Drug: TS-143
Other: Step2:6㎎ QD; Drug: TS-143 6mg Drug: Placebo	Drug: Placebo; Drug: TS-143
Other: Step3-1:11㎎ QD; Drug: TS-143 11mg Drug: Placebo	Drug: Placebo; Drug: TS-143
Other: Step3-2:11㎎ QD（Fed); Drug: TS-143 11mg Drug: Placebo	Drug: Placebo; Drug: TS-143
Other: Step4:20㎎ QD; Drug: TS-143 20mg Drug: Placebo	Drug: Placebo; Drug: TS-143
Other: Step5:36㎎ QD; Drug: TS-143 36mg Drug: Placebo	Drug: Placebo; Drug: TS-143

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2015
• Primary Completion (Actual): April 14, 2016
• Study Completion (Actual): April 14, 2016

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TS143-01-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No