- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02155543
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
March 10, 2016 updated by: Allergan
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Newport Beach, California, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
|
Experimental: 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.
|
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 2, 2014
First Posted (Estimate)
June 4, 2014
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
March 10, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 223575-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Inmagene LLCRecruitingHealthy VolunteersAustralia
Clinical Trials on AGN-223575 Formulation A
-
AllerganCompletedErythema | RosaceaUnited States
-
AllerganCompletedDry Eye SyndromesUnited States
-
AllerganCompletedOcular Hypertension | Primary Open-Angle GlaucomaUnited States
-
AllerganCompleted
-
ViiV HealthcareGlaxoSmithKlineNot yet recruiting
-
GlaxoSmithKlineCompletedMultiple SclerosisPoland, Germany, Czechia
-
Medicines for Malaria VentureRichmond Pharmacology LimitedCompleted
-
Lyndra Inc.CompletedHealthy | Gastric RetentionAustralia
-
Idorsia Pharmaceuticals Ltd.Completed
-
ViiV HealthcareRecruiting