Healthy VolunteersPhase 1NCT02155543
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
A Phase 1 study testing AGN-223575 Formulation A, AGN-223575 Formulation B and AGN-223575 Formulation C in people with Healthy Volunteers, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AGN-223575 Formulation A, AGN-223575 Formulation B and AGN-223575 Formulation C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight at least 110 lbs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- AGN-223575 Formulation A, AGN-223575 Formulation B, AGN-223575 Formulation C, AGN-223575 Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-223575 Formulation ADrug
One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
AGN-223575 Formulation BDrug
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.
AGN-223575 Formulation CDrug
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.
AGN-223575 VehicleDrug
One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AGN-223575 Form A/Vehicle | Experimental | 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. Receives: Drug: AGN-223575 Formulation A; Drug: AGN-223575 Vehicle |
| Cohort 2: AGN-223575 Formulation A BID | Experimental | 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. Receives: Drug: AGN-223575 Formulation A |
| Cohort 3: AGN-223575 Formulation B BID | Experimental | 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. Receives: Drug: AGN-223575 Formulation B |
| Cohort 4: AGN-223575 Formulation C BID | Experimental | 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. Receives: Drug: AGN-223575 Formulation C |
| AGN-223575 Vehicle BID | Placebo comparator | 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. Receives: Drug: AGN-223575 Vehicle |
| Cohort 5: AGN-223575 Formulation C TID | Experimental | 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. Receives: Drug: AGN-223575 Formulation C |
| AGN-223575 Vehicle TID | Placebo comparator | 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. Receives: Drug: AGN-223575 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155543
- Sponsor's protocol ID
- 223575-001
- Status last verified
- Mar 2016
- First submitted
- 2 Jun 2014
- Last updated
- 12 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02155543
- Acronym / sponsor ID
- 223575-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AGN-223575 Form A/Vehicle | Experimental | Drug: AGN-223575 Formulation A, Drug: AGN-223575 VehicleOne 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 | Experimental | Drug: AGN-223575 Formulation AOne 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 | Experimental | Drug: AGN-223575 Formulation BOne 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 | Experimental | Drug: AGN-223575 Formulation COne 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 comparator | Drug: AGN-223575 VehicleOne 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 | Experimental | Drug: AGN-223575 Formulation COne 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 comparator | Drug: AGN-223575 VehicleOne 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Weight at least 110 lbs
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-223575 Formulation AOne drop of AGN-223575 Formulation A administered in the study eye(s) per protocol. | Drug | Cohort 1: AGN-223575 Form A/Vehicle, Cohort 2: AGN-223575 Formulation A BID |
| AGN-223575 Formulation BOne 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. | Drug | Cohort 3: AGN-223575 Formulation B BID |
| AGN-223575 Formulation COne 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. | Drug | Cohort 4: AGN-223575 Formulation C BID, Cohort 5: AGN-223575 Formulation C TID |
| AGN-223575 VehicleOne drop of AGN-223575 vehicle administered in the study eye(s) per protocol. | Drug | AGN-223575 Vehicle BID, AGN-223575 Vehicle TID, Cohort 1: AGN-223575 Form A/Vehicle |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGN-223575 Formulation A, AGN-223575 Formulation B and AGN-223575 Formulation C in people with Healthy Volunteers, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Plasma Concentration (Cmax) of AGN-223575 (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.