NCT02650063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

January 4, 2016

Last Update Submit

June 28, 2016

Conditions

Healthy Male Adults

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

DE-117 ophthalmic solution

EXPERIMENTAL
Drug: DE-117

Interventions

DE-117DRUG
DE-117 ophthalmic solution

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male adult volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPC Clinical Trial Hospital, Medipolis Medical Research Institute

Kagoshima, Japan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

JP(1)