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

NCT03595202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

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.

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeru Okuyama · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595202 on ClinicalTrials.gov