NCT05905653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

27 days

First QC Date

May 25, 2023

Last Update Submit

December 3, 2023

Conditions

Healthy Adult Males Volunteers

Outcome Measures

Primary Outcomes (1)

  • Maximum Plasma Concentration [Cmax]

    Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

    1 week, Day 1 and Day 7

Secondary Outcomes (1)

  • Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]

    1 week, Day 1 and Day 7

Study Arms (1)

STN1012600 0.002%

EXPERIMENTAL
Drug: STN1012600 ophthalmic solution 0.002%

Interventions

STN1012600 ophthalmic solution 0.002%DRUG

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

STN1012600 0.002%

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Japan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 15, 2023

Study Start

May 25, 2023

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)