Healthy Volunteers
Conditions
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
Interventions
DRUGAGN-223575 Formulation A
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
DRUGAGN-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.
DRUGAGN-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.
DRUGAGN-223575 Vehicle
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| 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. | 9 |
| 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. | 9 |
| 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. | 3 |
| 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. | 3 |
| 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. | 9 |
| Total | 51 |
Baseline characteristics
| Characteristic | Cohort 5: AGN-223575 Formulation C TID | Cohort 4: AGN-223575 Formulation C BID | Cohort 3: AGN-223575 Formulation B BID | Cohort 2: AGN-223575 Formulation A BID | Cohort 1: AGN-223575 Form A/Vehicle | AGN-223575 Vehicle TID | AGN-223575 Vehicle BID | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized <45 years | 7 Participants | 8 Participants | 9 Participants | 9 Participants | 3 Participants | 3 Participants | 9 Participants | 48 Participants |
| Age, Customized Between 45 and 65 years | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 6 Participants | 5 Participants | 1 Participants | 2 Participants | 5 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 6 Participants | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 9 | 1 / 9 | 2 / 9 | 0 / 9 | 0 / 3 | 1 / 9 | 0 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Day 15
Population: Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 5: AGN-223575 Formulation C TID | Maximal Plasma Concentration (Cmax) of AGN-223575 | 0.186 Nanograms/Milliliters (ng/mL) | Standard Deviation 0.095 |
| Cohort 4: AGN-223575 Formulation C BID | Maximal Plasma Concentration (Cmax) of AGN-223575 | 0.128 Nanograms/Milliliters (ng/mL) | Standard Deviation 0.06 |
| Cohort 3: AGN-223575 Formulation B BID | Maximal Plasma Concentration (Cmax) of AGN-223575 | 0.114 Nanograms/Milliliters (ng/mL) | Standard Deviation 0.085 |
| Cohort 2: AGN-223575 Formulation A BID | Maximal Plasma Concentration (Cmax) of AGN-223575 | NA Nanograms/Milliliters (ng/mL) | — |