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

Phase 1CompletedNCT02155543

Allergan51 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

AGN-223575 Formulation ADRUG

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

AGN-223575 Formulation BDRUG

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 CDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Newport Beach, California, United States

Outcomes

Primary Outcomes

Maximal Plasma Concentration (Cmax) of AGN-223575

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.

Time frame: Day 15

Data from ClinicalTrials.gov

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