<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/NCT04504760</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-2910-01</org_study_id>
    <nct_id>NCT04504760</nct_id>
  </id_info>
  <brief_title>Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects</brief_title>
  <official_title>Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian 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>
    <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 and Caucasian subjects&#xD;
      when ONO-2910 is administered as single and multiple doses orally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is the First in Human (FIH) study to investigate safety, tolerability and&#xD;
      pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is&#xD;
      administered as single and multiple doses orally. Also, the purpose of this study is to&#xD;
      evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female&#xD;
      subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">March 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events [Safety and Tolerability]</measure>
    <time_frame>Up to 13 days</time_frame>
    <description>Number of participants with adverse events as assessed by CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the Cmax of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the Tmax of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC24h [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the AUC24h of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the AUClast of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the AUCinf of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the T1/2 of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F [Pharmacokinetic]</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Assessment of the CL/F of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fe [Pharmacokinetic]</measure>
    <time_frame>Up to 4 days</time_frame>
    <description>Assessment of the Vss of ONO-2910</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLr [Pharmacokinetic]</measure>
    <time_frame>Up to 4 days</time_frame>
    <description>Assessment of the CLr of ONO-2910</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>ONO-2910 (Part A and B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ONO-2910 (Part C and D)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part C and D)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-2910</intervention_name>
    <description>Single ascending dose of ONO-2910 will be administered orally.</description>
    <arm_group_label>ONO-2910 (Part A and B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single dose of placebo will be administered orally.</description>
    <arm_group_label>Placebo (Part A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-2910</intervention_name>
    <description>Multiple ascending dose of ONO-2910 will be administered orally.</description>
    <arm_group_label>ONO-2910 (Part C and D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Multiple dose of placebo will be administered orally.</description>
    <arm_group_label>Placebo (Part C and D)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Japanese healthy adult male subjects (Part A and C)&#xD;
&#xD;
          2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)&#xD;
&#xD;
          3. Caucasian healthy adult male subjects (Part D)&#xD;
&#xD;
          4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects currently with or with a history of 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masaharu Komeno</last_name>
    <role>Study Director</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tokyo Clinical Site 01</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04504760
org study id: ONO-2910-01
nct id: NCT04504760
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects
      when ONO-2910 is administered as single and multiple doses orally.
This study is the First in Human (FIH) study to investigate safety, tolerability and
      pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is
      administered as single and multiple doses orally. Also, the purpose of this study is to
      evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female
      subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events [Safety and Tolerability]
time frame: Up to 13 days
description: Number of participants with adverse events as assessed by CTCAE v5.0
measure: Cmax [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the Cmax of ONO-2910
measure: Tmax [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the Tmax of ONO-2910
measure: AUC24h [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the AUC24h of ONO-2910
measure: AUClast [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the AUClast of ONO-2910
measure: AUCinf [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the AUCinf of ONO-2910
measure: T1/2 [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the T1/2 of ONO-2910
measure: CL/F [Pharmacokinetic]
time frame: Up to 10 days
description: Assessment of the CL/F of ONO-2910
measure: fe [Pharmacokinetic]
time frame: Up to 4 days
description: Assessment of the Vss of ONO-2910
measure: CLr [Pharmacokinetic]
time frame: Up to 4 days
description: Assessment of the CLr of ONO-2910
arm group label: ONO-2910 (Part A and B)
arm group type: Experimental
arm group label: Placebo (Part A)
arm group type: Placebo Comparator
arm group label: ONO-2910 (Part C and D)
arm group type: Experimental
arm group label: Placebo (Part C and D)
arm group type: Placebo Comparator
intervention type: Drug
intervention name: ONO-2910
description: Single ascending dose of ONO-2910 will be administered orally.
arm group label: ONO-2910 (Part A and B)
intervention type: Drug
intervention name: Placebo
description: Single dose of placebo will be administered orally.
arm group label: Placebo (Part A)
intervention type: Drug
intervention name: ONO-2910
description: Multiple ascending dose of ONO-2910 will be administered orally.
arm group label: ONO-2910 (Part C and D)
intervention type: Drug
intervention name: Placebo
description: Multiple dose of placebo will be administered orally.
arm group label: Placebo (Part C and D)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Masaharu Komeno
role: Study Director
affiliation: Ono Pharmaceutical Co. Ltd
facility: 
country: Japan
responsible party type: Sponsor
sharing ipd: Yes
ipd description: https://www.ono.co.jp/eng/rd/policy.html