Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

December 3, 2023 updated by: Santen Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Medical Corporation Heishinkai OPHAC Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration [Cmax]
Time Frame: 1 week, Day 1 and Day 7
Calculate plasma pharmacokinetic parameters and study pharmacokinetics.
1 week, Day 1 and Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101260007LT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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