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

Phase I 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• 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
• Genders Eligible for Study: Male

Description

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:

1. 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

2. 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

3. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Step1:4㎎ TID; TS-143 12mg total dose/day or Placebo	Drug: TS-143; 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.; Drug: Placebo; 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.
Other: Step2:11㎎ TID; TS-143 33mg total dose/day or Placebo	Drug: TS-143; 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.; Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TS143-01-03

Drug and device information, study documents

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