<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/NCT04451083</url>
  </required_header>
  <id_info>
    <org_study_id>FOY-305-02</org_study_id>
    <nct_id>NCT04451083</nct_id>
  </id_info>
  <brief_title>Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects</brief_title>
  <official_title>Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male&#xD;
      subjects when FOY-305 is administered as multiple-dose orally.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">August 17, 2020</completion_date>
  <primary_completion_date type="Actual">August 17, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Number of participants with adverse events as assessed by CTCAE v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital sign [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital sign [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of pulse rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital sign [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of SpO2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (Heart Rate)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (RR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (PR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (QRS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (QT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG parameter test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of ECG parameter test (QTcF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of laboratory test (hematologic test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of laboratory test (blood biochemistry test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of laboratory test (blood coagulation test)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory test [Safety and Tolerability]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Summary statistics of laboratory test (urinalysis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 day</time_frame>
    <description>Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of FOY-251 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the CL of FOY-251 (Active metabolite of FOY-305)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>FOY-305</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOY-305</intervention_name>
    <description>Multiple-dose of FOY-305 will be administered orally at 4 times/day.</description>
    <arm_group_label>FOY-305</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Japanese healthy adult male subjects&#xD;
&#xD;
          2. Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas&#xD;
&#xD;
          3. BMI (at the time of screening test): ≥18.5 kg/m2, &lt;25.0 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are on a treatment for or with a history of respiratory, cardiovascular,&#xD;
             psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic&#xD;
             or endocrine and/or other disease.&#xD;
&#xD;
          2. Subjects with current or with a history of severe allergy to drugs or foods&#xD;
&#xD;
          3. Subjects with current or with a history of drug or alcohol abuse&#xD;
&#xD;
          4. Subjects with a history of hypersensitivity caused by ingredients of this drug&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susumu Nakade</last_name>
    <role>Study Director</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fukuoka Clinical Site 01</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Camostat</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.ono.co.jp/eng/rd/policy.html</ipd_description>
  </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/NCT04451083
org study id: FOY-305-02
nct id: NCT04451083
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male
      subjects when FOY-305 is administered as multiple-dose orally.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events [Safety and Tolerability]
time frame: Up to 10 days
description: Number of participants with adverse events as assessed by CTCAE v5.0
measure: Vital sign [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of blood pressure
measure: Vital sign [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of pulse rate
measure: Vital sign [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of SpO2
measure: Body temperature [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of body temperature
measure: Body weight [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of body weight
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (Heart Rate)
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (RR)
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (PR)
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (QRS)
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (QT)
measure: ECG parameter test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of ECG parameter test (QTcF)
measure: Laboratory test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of laboratory test (hematologic test)
measure: Laboratory test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of laboratory test (blood biochemistry test)
measure: Laboratory test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of laboratory test (blood coagulation test)
measure: Laboratory test [Safety and Tolerability]
time frame: Up to 10 days
description: Summary statistics of laboratory test (urinalysis)
measure: Cmax of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)
measure: Tmax of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)
measure: AUC of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)
measure: AUC of FOY-251 [Pharmacokinetic]
time frame: Up to 10 day
description: Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)
measure: AUC of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)
measure: T1/2 of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)
measure: CL/F of FOY-251 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the CL of FOY-251 (Active metabolite of FOY-305)
arm group label: FOY-305
arm group type: Experimental
intervention type: Drug
intervention name: FOY-305
description: Multiple-dose of FOY-305 will be administered orally at 4 times/day.
arm group label: FOY-305
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susumu Nakade
role: Study Director
affiliation: Ono Pharmaceutical Co. Ltd
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Camostat
sharing ipd: Yes
ipd description: https://www.ono.co.jp/eng/rd/policy.html