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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: TS-143; Drug: Placebo

• Registration Number: NCT03595202
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Study First Submitted: 2018-04-18
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-23
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Step1:4㎎ TID	Placebo	TS-143 12mg total dose/day or Placebo
Step1:4㎎ TID	TS-143	TS-143 12mg total dose/day or Placebo
Step2:11㎎ TID	Placebo	TS-143 33mg total dose/day or Placebo
Step2:11㎎ TID	TS-143	TS-143 33mg total dose/day or Placebo

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of unchanged form (ng/mL)	13 days
Reticulocyte count	13 days
Serum iron (μg／dL)	13 days
Incidence of subjects with adverse events	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.
Urinary excretions of unchanged form (ng/mL)	12 days
Serum EPO concentration	13 days
Total iron binding capacity（μg／dL）	13 days
Plasma vascular endothelial growth factor (VEGF) concentration	13 days

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan