<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04403763</url>
  </required_header>
  <id_info>
    <org_study_id>2011-101-013</org_study_id>
    <nct_id>NCT04403763</nct_id>
  </id_info>
  <brief_title>Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and&#xD;
      efficacy of AGN-241622 ophthalmic solution for the first time in human participants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company Decision&#xD;
  </why_stopped>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 5, 2022</completion_date>
  <primary_completion_date type="Actual">December 5, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622</measure>
    <time_frame>Up to 2 days</time_frame>
    <description>The number of patients who experience one or more TEAE during the treatment period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2a: Number of patients experiencing a treatment emergent adverse event after repeat administration of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>The number of patients who experience one or more TEAE during the treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1 Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pupil diameter measurement</measure>
    <time_frame>Day 1</time_frame>
    <description>To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Minimum plasma concentrations (Cmin) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Plasma Pharmacokinetics: Accumulation ratio of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2a Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622</measure>
    <time_frame>14 Days</time_frame>
    <description>To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>AGN-190584</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administered as single drop in each eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-241622 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as single drop in one eye or a single drop in each eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-241622 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as single drop in one eye or a single drop in each eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered as single drop in one eye or a single drop in each eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-241622 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as single drop in one eye or a single drop in each eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-241622</intervention_name>
    <description>Topical eye drop</description>
    <arm_group_label>AGN-241622 Dose 1</arm_group_label>
    <arm_group_label>AGN-241622 Dose 2</arm_group_label>
    <arm_group_label>AGN-241622 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-190584</intervention_name>
    <description>Topical eye drop</description>
    <arm_group_label>AGN-190584</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Topical eye drop</description>
    <arm_group_label>Placebo Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40 to 65 at the time of study participation.&#xD;
&#xD;
          -  Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.&#xD;
&#xD;
          -  Be able and willing to follow study instructions and complete all required study&#xD;
             visits in the opinion of the study doctor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of alcohol or substance abuse within the 5 years prior to study participation.&#xD;
&#xD;
          -  Enrollment in another investigational drug or device study within 30 days of study&#xD;
             participation.&#xD;
&#xD;
          -  Women who are pregnant, nursing, or planning a pregnancy during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>United Medical Research Institute /ID# 234612</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Research Foundation /ID# 237353</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90041-1718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Valley Eye Medical Group, Inc. /ID# 236686</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345-1200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Research Foundation /ID# 234526</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663-3637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Clinical Trials /ID# 237330</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannarr Eye Care /ID# 236718</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762-2620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Care Institute /ID# 234507</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care, PA /ID# 234454</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119-5745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PPD Clinical Research Unit - Austin /ID# 237644</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye associates /ID# 236502</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.AllerganClinicalTrials.com</url>
    <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</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 1, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Presbyopia,Healthy Subject,Subjects with Presbyopia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_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_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403763
org study id: 2011-101-013
nct id: NCT04403763
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Stage 1: Number of patients experiencing a treatment emergent adverse event after single administration of AGN-241622
time frame: Up to 2 days
description: The number of patients who experience one or more TEAE during the treatment period
measure: Stage 2a: Number of patients experiencing a treatment emergent adverse event after repeat administration of AGN-241622
time frame: 14 Days
description: The number of patients who experience one or more TEAE during the treatment period
measure: Stage 1 Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1 Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
time frame: Day 1
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
measure: Stage 1: Pupil diameter measurement
time frame: Day 1
description: To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants
measure: Stage 2a Plasma Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
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
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Minimum plasma concentrations (Cmin) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Apparent total clearance of AGN-241622 from plasma (CL/F)
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Plasma Pharmacokinetics: Accumulation ratio of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Tears Pharmacokinetics: Area under the concentration-time curve from time 0 to time t (AUC0-t) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
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
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Tears Pharmacokinetics: Maximum plasma concentrations (Cmax) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Tears Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Tears Pharmacokinetics: Terminal elimination rate constant (λz) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
measure: Stage 2a Tears Pharmacokinetics: Terminal elimination half-life (T1/2) of AGN-241622
time frame: 14 Days
description: To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
arm group label: AGN-190584
arm group type: Active Comparator
description: Administered as single drop in each eye
arm group label: AGN-241622 Dose 3
arm group type: Experimental
description: Administered as single drop in one eye or a single drop in each eye
arm group label: AGN-241622 Dose 2
arm group type: Experimental
description: Administered as single drop in one eye or a single drop in each eye
arm group label: Placebo Dose
arm group type: Placebo Comparator
description: Administered as single drop in one eye or a single drop in each eye
arm group label: AGN-241622 Dose 1
arm group type: Experimental
description: Administered as single drop in one eye or a single drop in each eye
intervention type: Drug
intervention name: AGN-241622
description: Topical eye drop
arm group label: AGN-241622 Dose 1
arm group label: AGN-241622 Dose 2
arm group label: AGN-241622 Dose 3
intervention type: Drug
intervention name: AGN-190584
description: Topical eye drop
arm group label: AGN-190584
intervention type: Drug
intervention name: Vehicle
description: Topical eye drop
arm group label: Placebo Dose
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
facility: 
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country: United States
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
responsible party type: Sponsor
mesh term: Presbyopia
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd 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 url: https://vivli.org/ourmember/abbvie/