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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155543
• Other study ID #: 223575-001
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2014
• Last updated: March 16, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AGN-223575 Formulation A
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
• AGN-223575 Formulation B
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
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
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Levels of AGN-223575		Day 15	No
Secondary	Drop Tolerability Score		Day 1, Day 2, Day 15	No