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A Phase I Study of TS-142 in Healthy Participants (Single Doses)

NCT04169893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-28

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Placebo (fasting)

Participants will receive placebo once in fasting condition

DRUG

Placebo (feeding)

Participants will receive placebo once after meal condition

DRUG

1 mg of TS-142

Participants will receive 1 mg of TS-142 once in fasting condition

DRUG

3 mg of TS-142

Participants will receive 3 mg of TS-142 once in fasting condition

DRUG

10 mg of TS-142 (fasting)

Participants will receive 10 mg of TS-142 once in fasting condition

DRUG

10 mg of TS-142 (feeding)

Participants will receive 10 mg of TS-142 once after meal condition

DRUG

30 mg of TS-142

Participants will receive 30 mg of TS-142 once in fasting condition

Sponsors & Collaborators

  • Taisho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeru Okuyama · Taisho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-10-17
Primary Completion
2016-02-06
Completion
2016-02-06

Countries

  • Japan

Study Locations

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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 NCT04169893 on ClinicalTrials.gov