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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AGN-223575 Vehicle; Drug: AGN-223575 Formulation A; Drug: AGN-223575 Formulation B; Drug: AGN-223575 Formulation C

• Registration Number: NCT02155543
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Results First Submitted: 2016-01-07
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Results First Posted: 2016-04-12
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AGN-223575 Vehicle TID	AGN-223575 Vehicle	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.
Cohort 1: AGN-223575 Form A/Vehicle	AGN-223575 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.
Cohort 2: AGN-223575 Formulation A BID	AGN-223575 Formulation A	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 Vehicle BID	AGN-223575 Vehicle	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.
Cohort 3: AGN-223575 Formulation B BID	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	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.
Cohort 1: AGN-223575 Form A/Vehicle	AGN-223575 Formulation A	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.
Cohort 5: AGN-223575 Formulation C TID	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 three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.

Primary Outcome Measures

Name	Time	Method
Maximal Plasma Concentration (Cmax) of AGN-223575	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.