Trial Outcomes & Findings for A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects (NCT NCT02155543)
NCT ID: NCT02155543
Last Updated: 2016-04-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Day 15
Results posted on
2016-04-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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 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 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.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
3
|
3
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 5: AGN-223575 Formulation C TID
n=9 Participants
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.
|
Cohort 4: AGN-223575 Formulation C BID
n=9 Participants
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 3: AGN-223575 Formulation B BID
n=9 Participants
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 2: AGN-223575 Formulation A BID
n=9 Participants
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.
|
Cohort 1: AGN-223575 Form A/Vehicle
n=3 Participants
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 Vehicle TID
n=3 Participants
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 BID
n=9 Participants
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.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
48 Participants
n=24 Participants
|
|
Age, Customized
Between 45 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
31 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)
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.
Outcome measures
| Measure |
Cohort 5: AGN-223575 Formulation C TID
n=9 Participants
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.
|
Cohort 4: AGN-223575 Formulation C BID
n=9 Participants
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 3: AGN-223575 Formulation B BID
n=9 Participants
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 2: AGN-223575 Formulation A BID
n=9 Participants
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.
|
|---|---|---|---|---|
|
Maximal Plasma Concentration (Cmax) of AGN-223575
|
0.186 Nanograms/Milliliters (ng/mL)
Standard Deviation 0.095
|
0.128 Nanograms/Milliliters (ng/mL)
Standard Deviation 0.060
|
0.114 Nanograms/Milliliters (ng/mL)
Standard Deviation 0.085
|
NA Nanograms/Milliliters (ng/mL)
Standard Deviation NA
Data were below the limit of quantitation (\< 0.02 ng/mL)
|
Adverse Events
Cohort 5: AGN-223575 Formulation C TID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: AGN-223575 Formulation C BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: AGN-223575 Formulation B BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: AGN-223575 Formulation A BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AGN-223575 Vehicle TID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AGN-223575 Vehicle BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: AGN-223575 Form A/Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 5: AGN-223575 Formulation C TID
n=9 participants at risk
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.
|
Cohort 4: AGN-223575 Formulation C BID
n=9 participants at risk
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 3: AGN-223575 Formulation B BID
n=9 participants at risk
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 2: AGN-223575 Formulation A BID
n=9 participants at risk
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 TID
n=3 participants at risk
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 BID
n=9 participants at risk
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 1: AGN-223575 Form A/Vehicle
n=3 participants at risk
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.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Punctate Keratitis
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eye Discharge
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
Investigations
Intraocular Pressure Increased
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
General disorders
Instillation Site Pain
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
11.1%
1/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/9
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
0.00%
0/3
The Safety Population included all subjects who received study drug (or vehicle) and was used to assess adverse events and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER