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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02650063

Enrollment

Registered

2016-01-08

Start date

2015-12-31

Completion date

2016-03-31

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Adults

Brief 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.

Interventions

DRUGDE-117

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male adult volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under concentration-time curve (AUC)	7 days
Maximum plasma concentration (Cmax)	7 days
Time to maximum plasma concentration (Tmax)	7 days
Elimination half-life (T1/2)	7 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026