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Completed

NCT Number: NCT02650063

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

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.

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Key information

Conditions

Healthy Male Adults

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CPC Clinical Trial Hospital, Medipolis Medical Research Institute

Kagoshima, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-117

Drug

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

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2016
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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