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OpenTrials
Completed

NCT Number: NCT02155543

A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Weight at least 110 lbs

Exclusion criteria

  • Use of contact lenses within 14 days, or planned use during the study
  • Use of any ocular eye medications within 30 days, or anticipated use during the study
  • Anticipated use of any artificial tears product during the study

Treatment and study plan

AGN-223575 Formulation A

Drug

One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.

AGN-223575 Formulation B

Drug

One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.

AGN-223575 Formulation C

Drug

One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.

AGN-223575 Vehicle

Drug

One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.

Primary outcomes

  1. Maximal Plasma Concentration (Cmax) of AGN-223575

    Time frame: Day 15

    Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 4, 2014
Registry last updated
Apr 12, 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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