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NCT04403763 Clinical Trial

Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia

Presbyopia Clinical Trial

Official title:
A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04403763
Other study ID # 2011-101-013
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date July 27, 2020
Est. completion date December 5, 2022

Study information
Verified date January 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants

Recruitment information / eligibility
Status Terminated
Enrollment 80
Est. completion date December 5, 2022
Est. primary completion date December 5, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Age 40 to 65 at the time of study participation. - Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year. - Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor. Exclusion Criteria: - History of alcohol or substance abuse within the 5 years prior to study participation. - Enrollment in another investigational drug or device study within 30 days of study participation. - Women who are pregnant, nursing, or planning a pregnancy during the study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AGN-241622
Topical eye drop
• Vehicle
Topical eye drop

Locations
Country Name City State
United States PPD Clinical Research Unit - Austin /ID# 237644 Austin Texas
United States United Medical Research Institute /ID# 234612 Inglewood California
United States Global Research Foundation /ID# 237353 Los Angeles California
United States The Eye Care Institute /ID# 234507 Louisville Kentucky
United States Total Eye Care, PA /ID# 234454 Memphis Tennessee
United States Quantum Clinical Trials /ID# 237330 Miami Beach Florida
United States North Valley Eye Medical Group, Inc. /ID# 236686 Mission Hills California
United States The Eye Research Foundation /ID# 234526 Newport Beach California
United States Kannarr Eye Care /ID# 236718 Pittsburg Kansas
United States Eye associates /ID# 236502 San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622 The number of participants who experience one or more TEAE during the treatment period Up to 2 days
Primary Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622 The number of patients who experience one or more TEAE during the treatment period 14 Days
Secondary Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (?z) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (?z) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants Day 1
Secondary Stage 1: Pupil Diameter Measurement To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants Day 1
Secondary Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (?z) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (?z) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
Secondary Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia 14 Days
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Completed NCT05359380 - The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
Not yet recruiting NCT04522427 - Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery N/A
Completed NCT03688425 - Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes N/A
Recruiting NCT06053463 - Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers N/A

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