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

Primary Purpose

Presbyopia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-241622
AGN-190584
Vehicle
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia,Healthy Subject,Subjects with Presbyopia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • United Medical Research Institute /ID# 234612
  • Global Research Foundation /ID# 237353
  • North Valley Eye Medical Group, Inc. /ID# 236686
  • The Eye Research Foundation /ID# 234526
  • Quantum Clinical Trials /ID# 237330
  • Kannarr Eye Care /ID# 236718
  • The Eye Care Institute /ID# 234507
  • Total Eye Care, PA /ID# 234454
  • PPD Clinical Research Unit - Austin /ID# 237644
  • Eye associates /ID# 236502

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

AGN-190584

AGN-241622 Dose 3

AGN-241622 Dose 2

Placebo Dose

AGN-241622 Dose 1

Arm Description

Administered as single drop in each eye

Administered as single drop in one eye or a single drop in each eye

Administered as single drop in one eye or a single drop in each eye

Administered as single drop in one eye or a single drop in each eye

Administered as single drop in one eye or a single drop in each eye

Outcomes

Primary Outcome Measures

Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622
The number of patients 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
The number of patients who experience one or more TEAE during the treatment period

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
Stage 1: Pupil diameter measurement
To evaluate the target receptor engagement of AGN-241622 as compared with vehicle 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
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
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
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
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
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
Stage 2a Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
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
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)
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
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
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
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
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
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
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
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
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia

Full Information

First Posted
May 1, 2020
Last Updated
June 16, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04403763
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Company Decision
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia,Healthy Subject,Subjects with Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-190584
Arm Type
Active Comparator
Arm Description
Administered as single drop in each eye
Arm Title
AGN-241622 Dose 3
Arm Type
Experimental
Arm Description
Administered as single drop in one eye or a single drop in each eye
Arm Title
AGN-241622 Dose 2
Arm Type
Experimental
Arm Description
Administered as single drop in one eye or a single drop in each eye
Arm Title
Placebo Dose
Arm Type
Placebo Comparator
Arm Description
Administered as single drop in one eye or a single drop in each eye
Arm Title
AGN-241622 Dose 1
Arm Type
Experimental
Arm Description
Administered as single drop in one eye or a single drop in each eye
Intervention Type
Drug
Intervention Name(s)
AGN-241622
Intervention Description
Topical eye drop
Intervention Type
Drug
Intervention Name(s)
AGN-190584
Intervention Description
Topical eye drop
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical eye drop
Primary Outcome Measure Information:
Title
Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622
Description
The number of patients who experience one or more TEAE during the treatment period
Time Frame
Up to 2 days
Title
Stage 2a: Number of patients experiencing a treatment emergent adverse event after repeat administration of AGN-241622
Description
The number of patients who experience one or more TEAE during the treatment period
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Stage 1 Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1 Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 1: Pupil diameter measurement
Description
To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants
Time Frame
Day 1
Title
Stage 2a Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
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
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Minimum plasma concentrations (Cmin) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Plasma Pharmacokinetics: Accumulation ratio of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
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
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days
Title
Stage 2a Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
Description
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
United Medical Research Institute /ID# 234612
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Global Research Foundation /ID# 237353
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041-1718
Country
United States
Facility Name
North Valley Eye Medical Group, Inc. /ID# 236686
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345-1200
Country
United States
Facility Name
The Eye Research Foundation /ID# 234526
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3637
Country
United States
Facility Name
Quantum Clinical Trials /ID# 237330
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Kannarr Eye Care /ID# 236718
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762-2620
Country
United States
Facility Name
The Eye Care Institute /ID# 234507
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Total Eye Care, PA /ID# 234454
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5745
Country
United States
Facility Name
PPD Clinical Research Unit - Austin /ID# 237644
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Name
Eye associates /ID# 236502
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance

Learn more about this trial

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

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