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CompletedNCT05905653Updated Dec 5, 2023

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

A Phase 1 interventional study of STN1012600 ophthalmic solution 0.002% in Healthy Adult Males Volunteers, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Santen Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Adult Males Volunteers
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    STN1012600 0.002%

    Drug: STN1012600 ophthalmic solution 0.002%

Interventions

  • DrugSTN1012600 ophthalmic solution 0.002%

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

05

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

    Time frame: 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]

    Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

    Time frame: 1 week, Day 1 and Day 7

06

Study locations

1 site
  • Medical Corporation Heishinkai OPHAC Hospital
    Osaka, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05905653
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
May 25, 2023
Primary completion
Jun 21, 2023
Completion
Jun 21, 2023
Last update
Dec 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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