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

Phase 1

Terminated

• Conditions: Presbyopia
• Interventions: Drug: AGN-241622; Drug: Vehicle

• Registration Number: NCT04403763
• Lead Sponsor: AbbVie

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2020-07-27
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05
• Results First Submitted: 2023-12-04
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Results First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3: AGN-241622 Dose 3 (High Dose)	AGN-241622	Administered as single drop in one eye
Cohort 1: AGN-241622 Dose 1 (Low Dose)	AGN-241622	Administered as single drop in one eye
Cohort 5: AGN-241622 Dose 2 (Medium Dose)	AGN-241622	Administered as single drop in each eye
Cohort 6: AGN-241622 Dose 3 (High Dose)	AGN-241622	Administered as single drop in each eye
Placebo Dose	Vehicle	Administered as single drop in one or both eyes
Cohort 2: AGN-241622 Dose 2 (Medium Dose)	AGN-241622	Administered as single drop in one eye
Cohort 4: AGN-241622 Dose 1 (Low Dose)	AGN-241622	Administered as a single drop in each eye

Primary Outcome Measures

Name	Time	Method
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622	Up to 2 days	The number of participants who experience one or more TEAE during the treatment period
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622	14 Days	The number of patients who experience one or more TEAE during the treatment period

Secondary Outcome Measures

Name	Time	Method
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)	Day 1	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	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 1: Pupil Diameter Measurement	Day 1	To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants
Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622	Day 1	To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
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	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
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	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622	14 Days	To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Trial Locations

Locations (10)

Kannarr Eye Care /ID# 236718; 🇺🇸 Pittsburg, Kansas, United States

North Valley Eye Medical Group, Inc. /ID# 236686; 🇺🇸 Mission Hills, California, United States

The Eye Care Institute /ID# 234507; 🇺🇸 Louisville, Kentucky, United States

Quantum Clinical Trials /ID# 237330; 🇺🇸 Miami Beach, Florida, United States

PPD Clinical Research Unit - Austin /ID# 237644; 🇺🇸 Austin, Texas, United States

Global Research Foundation /ID# 237353; 🇺🇸 Los Angeles, California, United States

The Eye Research Foundation /ID# 234526; 🇺🇸 Newport Beach, California, United States

United Medical Research Institute /ID# 234612; 🇺🇸 Inglewood, California, United States

Eye associates /ID# 236502; 🇺🇸 San Antonio, Texas, United States

Total Eye Care, PA /ID# 234454; 🇺🇸 Memphis, Tennessee, United States