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

Healthy Male Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650063
• Other study ID #: 01171502
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2016
• Last updated: June 28, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Adults

Intervention

Drug:
• DE-117

Locations

Country	Name	City	State
Japan	CPC Clinical Trial Hospital, Medipolis Medical Research Institute	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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