A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
1 other identifier
interventional
51
1 country
1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started May 2014
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
April 12, 2016
CompletedApril 12, 2016
March 1, 2016
7 months
June 2, 2014
January 7, 2016
March 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 15
Study Arms (7)
Cohort 1: AGN-223575 Form A/Vehicle
EXPERIMENTALOne 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.
Cohort 2: AGN-223575 Formulation A BID
EXPERIMENTALOne 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.
Cohort 3: AGN-223575 Formulation B BID
EXPERIMENTALOne 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
EXPERIMENTALOne 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
PLACEBO COMPARATOROne 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.
Cohort 5: AGN-223575 Formulation C TID
EXPERIMENTALOne 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 Vehicle TID
PLACEBO COMPARATOROne 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.
Interventions
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
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.
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.
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Eligibility Criteria
You may qualify if:
- Weight at least 110 lbs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Newport Beach, California, United States
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 4, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
April 12, 2016
Results First Posted
April 12, 2016
Record last verified: 2016-03