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CompletedNCT02650063Updated Jun 29, 2016

A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -

A Phase 1 interventional study of DE-117 in Healthy Male Adults, sponsored by Santen Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-29.

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

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.

02

Conditions studied

  • Healthy Male Adults
03

In context

Lead sponsor

Santen Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male adult volunteers

Exclusion criteria

Exclusion Criteria:

  • Subjects with any history of severe diseases that preclude participation in this study for safety reasons
  • Subjects with any diseases that preclude participation in this study for safety reasons
05

Study design

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

Study arms

  • Experimental
    DE-117 ophthalmic solution

    Drug: DE-117

Interventions

  • DrugDE-117
06

What researchers measure

Primary outcomes

  1. Area under concentration-time curve (AUC)

    Time frame: 7 days

  2. Maximum plasma concentration (Cmax)

    Time frame: 7 days

  3. Time to maximum plasma concentration (Tmax)

    Time frame: 7 days

  4. Elimination half-life (T1/2)

    Time frame: 7 days

07

Study locations

1 site
  • CPC Clinical Trial Hospital, Medipolis Medical Research Institute
    Kagoshima, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02650063
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 8, 2016
Start date
Dec 2015
Primary completion
Feb 2016
Completion
Mar 2016
Last update
Jun 29, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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