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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04403763

Collaborator

(none)

144

Enrollment

Locations

Arms

35.1

Anticipated Duration (Months)

13.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: AGN-241622 Drug: AGN-190584 Drug: Vehicle	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jul 27, 2020

Anticipated Primary Completion Date :

Aug 8, 2022

Anticipated Study Completion Date :

Jun 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-241622 Dose 1 Administered as single drop in one eye or a single drop in each eye	Drug: AGN-241622 Topical eye drop
Placebo Comparator: Placebo Dose Administered as single drop in one eye or a single drop in each eye	Drug: Vehicle Topical eye drop
Experimental: AGN-241622 Dose 2 Administered as single drop in one eye or a single drop in each eye	Drug: AGN-241622 Topical eye drop
Experimental: AGN-241622 Dose 3 Administered as single drop in one eye or a single drop in each eye	Drug: AGN-241622 Topical eye drop
Active Comparator: AGN-190584 Administered as single drop in each eye	Drug: AGN-190584 Topical eye drop

Outcome Measures

Primary Outcome Measures

Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622 [Up to 2 days]
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 [14 Days]
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 [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: 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: 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 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 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: 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: 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 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 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 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: 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: 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 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: 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: 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Medical Research Institute /ID# 234612	Inglewood	California	United States	90301
2	Global Research Foundation /ID# 237353	Los Angeles	California	United States	90041-1718
3	North Valley Eye Medical Group, Inc. /ID# 236686	Mission Hills	California	United States	91345-1200
4	The Eye Research Foundation /ID# 234526	Newport Beach	California	United States	92663-3637
5	Clinical Research Center FL /ID# 237330	Pompano Beach	Florida	United States	33060
6	Kannarr Eye Care /ID# 236718	Pittsburg	Kansas	United States	66762-2620
7	The Eye Care Institute /ID# 234507	Louisville	Kentucky	United States	40206
8	Total Eye Care, PA /ID# 234454	Memphis	Tennessee	United States	38119-5745
9	PPD Clinical Research Unit - Austin /ID# 237644	Austin	Texas	United States	78744
10	Eye associates /ID# 236502	San Antonio	Texas	United States	78229
11	Hoopes, Durrie, Rivera Research /ID# 236689	Draper	Utah	United States	84020-7133

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT04403763

Other Study ID Numbers:

2011-101-013

First Posted:

May 27, 2020

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Presbyopia,Healthy Subject,Subjects with Presbyopia

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Apr 19, 2022