Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

Phase 1

Completed

• Conditions: Healthy Adult Males Volunteers
• Interventions: Drug: STN1012600 ophthalmic solution 0.002%

• Registration Number: NCT05905653
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol

Exclusion Criteria

• Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
• Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STN1012600 0.002%	STN1012600 ophthalmic solution 0.002%	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	1 week, Day 1 and Day 7	Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

Secondary Outcome Measures

Name	Time	Method
Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]	1 week, Day 1 and Day 7	Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

Trial Locations

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka, Japan