Pharmacokinetic Study of STN1012600 Ophthalmic Solution i... | NCT05905653

Studies
Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

NCT05905653

Sponsor

Santen Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Healthy Adult Males Volunteers

Interventions

STN1012600 ophthalmic solution 0.002%

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2023Actual

Primary Completion Date

Jun 21, 2023Actual

Completion Date

Jun 21, 2023Actual

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

Jun 6, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STN1012600 0.002%	Experimental		Drug: STN1012600 ophthalmic solution 0.002%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
STN1012600 ophthalmic solution 0.002%	Drug	1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days	STN1012600 0.002%

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Corporation Heishinkai OPHAC Hospital		Osaka			Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided