Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759339
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2021-02-15
Brief Title:
An Open Label Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
Sponsor:
American Genomics LLC
Organization:
American Genomics LLC
Study Overview
Official Title:
An Open Label Non-Comparative Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of Articaine Sterile Topical Ophthalmic Solution AG-920
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 open-label non-comparative study in healthy subjects performed in the US It is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye
Detailed Description:
This is a Phase 1 open-label non-comparative study in healthy subjects designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye
In this study subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye The study eye will be randomized The single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye Subjects will have pharmacokinetic PK blood samples taken at multiple periods over 24 hours following dosing Safety will be assessed by monitoring any changes in heart rate blood pressure intraocular pressure visual acuity biomicroscopy and AEs
The study will consist of 3 clinical visits Screening Visit Dosing and PK Blood Level Sampling 0-8 hours Visit and a Follow Up Visit with PK blood level sampling 24 hours after study drug treatment
In this study subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye The study eye will be randomized The single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye Subjects will have pharmacokinetic PK blood samples taken at multiple periods over 24 hours following dosing Safety will be assessed by monitoring any changes in heart rate blood pressure intraocular pressure visual acuity biomicroscopy and AEs
The study will consist of 3 clinical visits Screening Visit Dosing and PK Blood Level Sampling 0-8 hours Visit and a Follow Up Visit with PK blood level sampling 24 hours after study drug treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None