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

Phase 2TerminatedNCT04403763

AbbVie80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Presbyopia

Interventions

AGN-241622DRUG

Topical eye drop

VehicleDRUG

Topical eye drop

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (10)

United Medical Research Institute /ID# 234612

Inglewood, California, United States

Global Research Foundation /ID# 237353

Los Angeles, California, United States

North Valley Eye Medical Group, Inc. /ID# 236686

Mission Hills, California, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 2 days

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

Time frame: 14 Days

Secondary Outcomes

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

Time frame: Day 1

Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)

Data from ClinicalTrials.gov

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The Eye Research Foundation /ID# 234526

Newport Beach, California, United States

Quantum Clinical Trials /ID# 237330

Miami Beach, Florida, United States

Kannarr Eye Care /ID# 236718

Pittsburg, Kansas, United States

The Eye Care Institute /ID# 234507

Louisville, Kentucky, United States

Total Eye Care, PA /ID# 234454

Memphis, Tennessee, United States

PPD Clinical Research Unit - Austin /ID# 237644

Austin, Texas, United States

Eye associates /ID# 236502

San Antonio, Texas, United States

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

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

Time frame: Day 1

Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622

To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants

Time frame: Day 1

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

Time frame: Day 1

Stage 1: Pupil Diameter Measurement

To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants

Time frame: Day 1

Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622