NCT04169893

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

A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Taisho Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-10-17
• Primary completion: 2016-02-06
• Completion: 2016-02-06
• First posted: 2019-11-20
• Last updated: 2025-02-28

Locations

1 site across 1 country: Japan