Clinical trial NCT04403763: Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Presbyopia
Keywords: Presbyopia,Healthy Subject,Subjects with Presbyopia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
timeFrame: Up to 2 days
measure: Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
timeFrame: 14 Days
Secondary outcomes:
measure: Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
timeFrame: Day 1
measure: Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
timeFrame: Day 1
measure: Stage 1: Pupil Diameter Measurement
timeFrame: Day 1
measure: Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
timeFrame: 14 Days
measure: 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
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
timeFrame: 14 Days
measure: 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
timeFrame: 14 Days
measure: Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
timeFrame: 14 Days
measure: Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
timeFrame: 14 Days
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute /ID# 234612
state: California
city: Los Angeles
country: United States
facility: Global Research Foundation /ID# 237353
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc. /ID# 236686
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 234526
state: California
city: Miami Beach
country: United States
facility: Quantum Clinical Trials /ID# 237330
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care /ID# 236718
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Institute /ID# 234507
state: Kentucky
city: Memphis
country: United States
facility: Total Eye Care, PA /ID# 234454
state: Tennessee
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 237644
state: Texas
city: San Antonio
country: United States
facility: Eye associates /ID# 236502
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: