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

Phase 1

Completed

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

• Registration Number: NCT03591133
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-24
• Primary Completion: 2016-04-14
• Study Completion: 2016-04-14
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-19
• Status Verified: 2023-06
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Step4:20㎎ QD	Placebo	Drug: TS-143 20mg Drug: Placebo
Step2:6㎎ QD	Placebo	Drug: TS-143 6mg Drug: Placebo
Step5:36㎎ QD	TS-143	Drug: TS-143 36mg Drug: Placebo
Step1:3㎎ QD	Placebo	Drug: TS-143 3mg Drug: Placebo
Step1:3㎎ QD	TS-143	Drug: TS-143 3mg Drug: Placebo
Step3-1:11㎎ QD	TS-143	Drug: TS-143 11mg Drug: Placebo
Step3-2:11㎎ QD（Fed)	TS-143	Drug: TS-143 11mg Drug: Placebo
Step3-2:11㎎ QD（Fed)	Placebo	Drug: TS-143 11mg Drug: Placebo
Step3-1:11㎎ QD	Placebo	Drug: TS-143 11mg Drug: Placebo
Step5:36㎎ QD	Placebo	Drug: TS-143 36mg Drug: Placebo
Step4:20㎎ QD	TS-143	Drug: TS-143 20mg Drug: Placebo
Step2:6㎎ QD	TS-143	Drug: TS-143 6mg Drug: Placebo

Primary Outcome Measures

Name	Time	Method
Serum erythropoietin (EPO) concentration	72 hours
Plasma concentrations of unchanged form (ng/mL)	72 hours	The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Incidence of adverse events	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.
Urinary excretions of unchanged form (ng/mL)	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.

Trial Locations

Locations (1)

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