NCT04979572

A Phase I Study of TS-172 in Healthy Adult Subjects (Single and Multiple Doses)

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Taisho Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	TS-172	* Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting) * Multiple dose of TS-172 90 mg before breakfast and dinner
DRUG	Placebo	* Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2) * Multiple dose of TS-172 placebo before breakfast and dinner

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2021-07-28
• Last updated: 2025-02-28

Locations

1 site across 1 country: Japan