A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
NCT ID: NCT02155543
Last Updated: 2016-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2014-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1: AGN-223575 Form A/Vehicle
One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
AGN-223575 Formulation A
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
AGN-223575 Vehicle
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Cohort 2: AGN-223575 Formulation A BID
One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
AGN-223575 Formulation A
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
Cohort 3: AGN-223575 Formulation B BID
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 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.
Cohort 4: AGN-223575 Formulation C BID
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 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 BID
One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
AGN-223575 Vehicle
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Cohort 5: AGN-223575 Formulation C TID
One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C 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 TID
One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
AGN-223575 Vehicle
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Newport Beach, California, United States
Countries
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Other Identifiers
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223575-001
Identifier Type: -
Identifier Source: org_study_id
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