<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/NCT02243657</url>
  </required_header>
  <id_info>
    <org_study_id>3652-CL-0002</org_study_id>
    <secondary_id>2008-006416-38</secondary_id>
    <nct_id>NCT02243657</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3652 in Healthy Young and Elderly Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Europe B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates how safe ASP3652 is and how well it is tolerated when taken as&#xD;
      multiple doses. The study also assesses how quickly and to what extent it is absorbed and&#xD;
      eliminated from the body. In addition, the effects of age and gender are investigated.&#xD;
&#xD;
      The study consists of two parts. In Part 1 four dose levels are administered to four separate&#xD;
      groups initially. Two additional dosages are then investigated. Subjects receive either a&#xD;
      once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.&#xD;
&#xD;
      Part 2 is performed in one group of elderly healthy male or female (post-menopausal)&#xD;
      subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.&#xD;
&#xD;
      For both parts of the study, the subjects stay in the clinic for one period of 18 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes&#xD;
      place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged&#xD;
      on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early)&#xD;
      discharge.&#xD;
&#xD;
      Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of&#xD;
      ASP3652 following ascending multiple oral doses. The initially planned four dose levels or&#xD;
      matching placebo are given to four separate groups. Thereafter two additional dosage levels&#xD;
      are further investigated. All groups receive a single dose of ASP3652 administered in the&#xD;
      morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under&#xD;
      fasted conditions, except the last group which receives all dosages once daily from Day 1 to&#xD;
      Day 14.&#xD;
&#xD;
      Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple&#xD;
      oral doses in healthy elderly male and female subjects. This part contains a single,&#xD;
      placebo-controlled group. All subjects receive twice daily doses and administration is based&#xD;
      on the results of Part 1.&#xD;
&#xD;
      All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests&#xD;
      for monitoring of psychotropic effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">May 2010</completion_date>
  <primary_completion_date type="Actual">May 2010</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nature, frequency and severity of adverse events</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical examination and vital signs</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Routine safety laboratory tests</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>12 -lead Electrocardiogram (ECG)</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Holter ECG</measure>
    <time_frame>Day -1 and Day14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Monitoring of psychotropic / cannabinoids-like effects</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognition Test Battery (NTB)</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examination for skin lesions</measure>
    <time_frame>Screening to 14 days after discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic (PK) profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to infinity (AUCinf)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by maximum plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by time to attain Cmax (tmax)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by elimination half-life (t½)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by absorption lag time (tlag)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by apparent volume of distribution during the terminal phase (Vz/F)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for first dose measured by apparent total clearance of the drug from plasma after oral administration (CL/F)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf%)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for first dose measured by renal clearance of the drug from plasma (CLR)</measure>
    <time_frame>Day 1 to Day 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by area under the plasma concentration - time curve between consecutive dosing (AUCtau)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for Bis in die (twice daily) (BID) dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by area under the plasma concentration- time curve from the time of dosing up to 24 hours (AUC0-24)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for BID dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by tmax</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by Cmax</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by t½</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by Vz/F</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by CL/F</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by accumulation ratio (Rac)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by Peak Trough Ratio (PTR)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in plasma for last dose measured by plasma concentration at the end of a dosing interval at steady state (Ctrough)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for last dose measured by cumulative amount of drug excreted into urine over the time interval between consecutive dosing (Aetau)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for BID dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for last dose measured by fraction of the drug excreted into urine (Aetau) over the time interval between consecutive dosing (Aetau%)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for BID dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for last dose measured by CLR</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for BID dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for last dose measured by cumulative amount of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
    <description>Only for BID dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile in urine for last dose measured by percentage of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24%)</measure>
    <time_frame>Day 14 to Day 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacodynamics measured by Ex vivo enzyme activity in mononuclear cells</measure>
    <time_frame>Day -1 to Day 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics measured by levels of arachidonoyl-ethanolamide (AEA) in plasma and seminal fluid (exploratory)</measure>
    <time_frame>Day -2 or -1 and day 11, 12 or 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics measured by levels of oleoyl-ethanolamide (OEA) in plasma and seminal fluid (exploratory)</measure>
    <time_frame>Day -2 or -1 and day 11, 12 or 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics measured by levels of palmitoyl-ethanolamide (PEA) in plasma and seminal fluid (exploratory)</measure>
    <time_frame>Day -2 or -1 and day 11, 12 or 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacodynamics measured by intraocular pressure (IOP) (exploratory)</measure>
    <time_frame>Day -1 to Day 15</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Healthy Subjects</condition>
  <condition>Pharmacokinetics of ASP3652</condition>
  <condition>Pharmacodynamics of ASP3652</condition>
  <arm_group>
    <arm_group_label>1: Placebo dose level</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2: ASP3652 lowest dose level twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>3:ASP3652 low dose level twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>4: ASP3652 medium dose level twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>5: ASP3652 high dose level twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>6: ASP3652 highest dose level once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP3652</intervention_name>
    <description>oral</description>
    <arm_group_label>2: ASP3652 lowest dose level twice daily</arm_group_label>
    <arm_group_label>3:ASP3652 low dose level twice daily</arm_group_label>
    <arm_group_label>4: ASP3652 medium dose level twice daily</arm_group_label>
    <arm_group_label>5: ASP3652 high dose level twice daily</arm_group_label>
    <arm_group_label>6: ASP3652 highest dose level once daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>1: Placebo dose level</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.&#xD;
&#xD;
          -  Male subject is non-fertile, i.e. surgically sterilized or practices an adequate&#xD;
             contraceptive method to prevent pregnancies.&#xD;
&#xD;
          -  Female subject is of non-child bearing potential, i.e. post menopausal, surgically&#xD;
             sterilized, hysterectomy in medical history, or practices adequate (double barrier)&#xD;
             non-hormonal contraceptive method to prevent pregnancies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding within 6 months before screening assessment.&#xD;
&#xD;
          -  Presence or history of any clinically significant psychiatric disorder such as mania,&#xD;
             depression or schizophrenia.&#xD;
&#xD;
          -  Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3&#xD;
             months prior to admission to the Clinical Unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Central Contact</last_name>
    <role>Study Chair</role>
    <affiliation>Astellas Pharma Europe B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRA International</name>
      <address>
        <city>Groningen</city>
        <zip>9713GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP3652</keyword>
  <keyword>Age</keyword>
  <keyword>Gender</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Multiple Ascending Doses (MAD)</keyword>
  <!-- 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/NCT02243657
org study id: 3652-CL-0002
secondary id: 2008-006416-38
nct id: NCT02243657
lead sponsor: 
has dmc: No
The study investigates how safe ASP3652 is and how well it is tolerated when taken as
      multiple doses. The study also assesses how quickly and to what extent it is absorbed and
      eliminated from the body. In addition, the effects of age and gender are investigated.

      The study consists of two parts. In Part 1 four dose levels are administered to four separate
      groups initially. Two additional dosages are then investigated. Subjects receive either a
      once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.

      Part 2 is performed in one group of elderly healthy male or female (post-menopausal)
      subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.

      For both parts of the study, the subjects stay in the clinic for one period of 18 days.
This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes
      place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged
      on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early)
      discharge.

      Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
      ASP3652 following ascending multiple oral doses. The initially planned four dose levels or
      matching placebo are given to four separate groups. Thereafter two additional dosage levels
      are further investigated. All groups receive a single dose of ASP3652 administered in the
      morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under
      fasted conditions, except the last group which receives all dosages once daily from Day 1 to
      Day 14.

      Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple
      oral doses in healthy elderly male and female subjects. This part contains a single,
      placebo-controlled group. All subjects receive twice daily doses and administration is based
      on the results of Part 1.

      All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests
      for monitoring of psychotropic effects.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Nature, frequency and severity of adverse events
time frame: Screening to 14 days after discharge
measure: Physical examination and vital signs
time frame: Screening to 14 days after discharge
measure: Body temperature
time frame: Screening to 14 days after discharge
measure: Routine safety laboratory tests
time frame: Screening to 14 days after discharge
measure: 12 -lead Electrocardiogram (ECG)
time frame: Screening to 14 days after discharge
measure: Holter ECG
time frame: Day -1 and Day14
measure: Monitoring of psychotropic / cannabinoids-like effects
time frame: Screening to 14 days after discharge
measure: Neurocognition Test Battery (NTB)
time frame: Screening to 14 days after discharge
measure: Examination for skin lesions
time frame: Screening to 14 days after discharge
measure: Pharmacokinetic (PK) profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to infinity (AUCinf)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by maximum plasma concentration (Cmax)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by time to attain Cmax (tmax)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by elimination half-life (t½)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by absorption lag time (tlag)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by apparent volume of distribution during the terminal phase (Vz/F)
time frame: Day 1 to Day 2
measure: PK profile in plasma for first dose measured by apparent total clearance of the drug from plasma after oral administration (CL/F)
time frame: Day 1 to Day 2
measure: PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast)
time frame: Day 1 to Day 2
measure: PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf)
time frame: Day 1 to Day 2
measure: PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
time frame: Day 1 to Day 2
measure: PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf%)
time frame: Day 1 to Day 2
measure: PK profile in urine for first dose measured by renal clearance of the drug from plasma (CLR)
time frame: Day 1 to Day 2
measure: PK profile in plasma for last dose measured by area under the plasma concentration - time curve between consecutive dosing (AUCtau)
time frame: Day 14 to Day 16
description: Only for Bis in die (twice daily) (BID) dosing
measure: PK profile in plasma for last dose measured by area under the plasma concentration- time curve from the time of dosing up to 24 hours (AUC0-24)
time frame: Day 14 to Day 16
description: Only for BID dosing
measure: PK profile in plasma for last dose measured by tmax
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by Cmax
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by t½
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by Vz/F
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by CL/F
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by accumulation ratio (Rac)
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by Peak Trough Ratio (PTR)
time frame: Day 14 to Day 16
measure: PK profile in plasma for last dose measured by plasma concentration at the end of a dosing interval at steady state (Ctrough)
time frame: Day 14 to Day 16
measure: PK profile in urine for last dose measured by cumulative amount of drug excreted into urine over the time interval between consecutive dosing (Aetau)
time frame: Day 14 to Day 16
description: Only for BID dosing
measure: PK profile in urine for last dose measured by fraction of the drug excreted into urine (Aetau) over the time interval between consecutive dosing (Aetau%)
time frame: Day 14 to Day 16
description: Only for BID dosing
measure: PK profile in urine for last dose measured by CLR
time frame: Day 14 to Day 16
description: Only for BID dosing
measure: PK profile in urine for last dose measured by cumulative amount of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24)
time frame: Day 14 to Day 16
description: Only for BID dosing
measure: PK profile in urine for last dose measured by percentage of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24%)
time frame: Day 14 to Day 16
measure: Assessment of Pharmacodynamics measured by Ex vivo enzyme activity in mononuclear cells
time frame: Day -1 to Day 16
measure: Pharmacodynamics measured by levels of arachidonoyl-ethanolamide (AEA) in plasma and seminal fluid (exploratory)
time frame: Day -2 or -1 and day 11, 12 or 13
measure: Pharmacodynamics measured by levels of oleoyl-ethanolamide (OEA) in plasma and seminal fluid (exploratory)
time frame: Day -2 or -1 and day 11, 12 or 13
measure: Pharmacodynamics measured by levels of palmitoyl-ethanolamide (PEA) in plasma and seminal fluid (exploratory)
time frame: Day -2 or -1 and day 11, 12 or 13
measure: Assessment of Pharmacodynamics measured by intraocular pressure (IOP) (exploratory)
time frame: Day -1 to Day 15
arm group label: 1: Placebo dose level
arm group type: Placebo Comparator
arm group label: 2: ASP3652 lowest dose level twice daily
arm group type: Experimental
arm group label: 3:ASP3652 low dose level twice daily
arm group type: Experimental
arm group label: 4: ASP3652 medium dose level twice daily
arm group type: Experimental
arm group label: 5: ASP3652 high dose level twice daily
arm group type: Experimental
arm group label: 6: ASP3652 highest dose level once daily
arm group type: Experimental
intervention type: Drug
intervention name: ASP3652
description: oral
arm group label: 2: ASP3652 lowest dose level twice daily
arm group label: 3:ASP3652 low dose level twice daily
arm group label: 4: ASP3652 medium dose level twice daily
arm group label: 5: ASP3652 high dose level twice daily
arm group label: 6: ASP3652 highest dose level once daily
intervention type: Drug
intervention name: Placebo
description: oral
arm group label: 1: Placebo dose level
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Central Contact
role: Study Chair
affiliation: Astellas Pharma Europe B.V.
facility: 
country: Netherlands
responsible party type: Sponsor