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

• Sponsor: Santen Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02650063
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Male Adults	Drug: DE-117	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DE-117 ophthalmic solution	Drug: DE-117

Outcome Measures

Primary Outcome Measures

1. Area under concentration-time curve (AUC) [7 days]

2. Maximum plasma concentration (Cmax) [7 days]

3. Time to maximum plasma concentration (Tmax) [7 days]

4. Elimination half-life (T1/2) [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CPC Clinical Trial Hospital, Medipolis Medical Research Institute	Kagoshima		Japan

Sponsors and Collaborators

• Santen Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02650063
• Other Study ID Numbers: 01171502
• First Posted: Jan 8, 2016
• Last Update Posted: Jun 29, 2016
• Last Verified: Jun 1, 2016

Study Results

No Results Posted as of Jun 29, 2016