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Clinical Trials/NCT05905653
NCT05905653
Completed
Phase 1

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

Santen Pharmaceutical Co., Ltd.1 site in 1 country8 target enrollmentMay 25, 2023
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ConditionsHealthy Adult Males Volunteers
InterventionsSTN1012600 ophthalmic solution 0.002%

Overview

Phase
Phase 1
Intervention
STN1012600 ophthalmic solution 0.002%
Conditions
Healthy Adult Males Volunteers
Sponsor
Santen Pharmaceutical Co., Ltd.
Enrollment
8
Locations
1
Primary Endpoint
Maximum Plasma Concentration [Cmax]
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2023
End Date
June 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

STN1012600 0.002%

Intervention: STN1012600 ophthalmic solution 0.002%

Outcomes

Primary Outcomes

Maximum Plasma Concentration [Cmax]

Time Frame: 1 week, Day 1 and Day 7

Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

Secondary Outcomes

  • Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t](1 week, Day 1 and Day 7)

Study Sites (1)

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