Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

Sponsor

Santen Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05905653

Collaborator

(none)

Enrollment

Location

Arm

1.2

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Males Volunteers	Drug: STN1012600 ophthalmic solution 0.002%	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

Actual Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STN1012600 0.002%	Drug: STN1012600 ophthalmic solution 0.002% 1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days

Arm

Intervention/Treatment

Experimental: STN1012600 0.002%

Drug: STN1012600 ophthalmic solution 0.002%

1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Corporation Heishinkai OPHAC Hospital	Osaka		Japan

Sponsors and Collaborators

Santen Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Santen Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05905653

Other Study ID Numbers:

101260007LT

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ophthalmic Solutions

Study Results

No Results Posted as of Jun 15, 2023