<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/NCT01675518</url>
  </required_header>
  <id_info>
    <org_study_id>7991-CL-0001</org_study_id>
    <nct_id>NCT01675518</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers</brief_title>
  <official_title>A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Oral Administration of ASP7991 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</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>
      This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics&#xD;
      of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is&#xD;
      administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991&#xD;
      in fasted and fed conditions are compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of two parts. In Part 1, the study will begin as a single rising dose&#xD;
      escalation design under randomized double-blind and fasting conditions. In each dose group,&#xD;
      volunteers will be randomized to receive an oral administration of either active drug&#xD;
      (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.&#xD;
&#xD;
      Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to&#xD;
      volunteers under 2 conditions, fasting and fed, on 2-way crossover method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs</measure>
    <time_frame>for 96 hours after dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F</measure>
    <time_frame>for 96 hours after dosing</time_frame>
    <description>Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr</measure>
    <time_frame>for 96 hour after dosing</time_frame>
    <description>Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma parathyroid hormon concentration</measure>
    <time_frame>for 96 hours after dosing</time_frame>
    <description>Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <condition>Pharmacokinetics of ASP7991</condition>
  <arm_group>
    <arm_group_label>Part-1 dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 dose 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 dose 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-1 placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-2 fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part-2 fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP7991</intervention_name>
    <description>oral</description>
    <arm_group_label>Part-1 dose 1</arm_group_label>
    <arm_group_label>Part-1 dose 2</arm_group_label>
    <arm_group_label>Part-1 dose 3</arm_group_label>
    <arm_group_label>Part-1 dose 4</arm_group_label>
    <arm_group_label>Part-1 dose 5</arm_group_label>
    <arm_group_label>Part-1 dose 6</arm_group_label>
    <arm_group_label>Part-2 fasted</arm_group_label>
    <arm_group_label>Part-2 fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>Part-1 placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, as judged by the investigator/sub investigator based on the results of&#xD;
             physical examination obtained before study drug administration&#xD;
&#xD;
          -  Body weight: ≥50.0 kg, &lt;80.0 kg&#xD;
&#xD;
          -  BMI: ≥17.6, &lt;26.4&#xD;
&#xD;
          -  Serum corrected calcium concentration: ≥9.0mg/dL, &lt;10.4 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received any investigational drugs in other clinical or post-marketing studies within&#xD;
             120 days before screening&#xD;
&#xD;
          -  Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or&#xD;
             blood components within 14 days before screening&#xD;
&#xD;
          -  Received medication (including marketed drug) within 7 days before hospitalization,&#xD;
             vitamin preparation including vitamin D and supplement including calcium or is&#xD;
             scheduled to receive medication&#xD;
&#xD;
          -  A deviation from normal criteria range of 12-lead ECG (QT evaluation)&#xD;
&#xD;
          -  A deviation from the normal range in clinical laboratory tests&#xD;
&#xD;
          -  Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL&#xD;
&#xD;
          -  History of drug allergies&#xD;
&#xD;
          -  Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days&#xD;
             before admission&#xD;
&#xD;
          -  Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver&#xD;
             injury)&#xD;
&#xD;
          -  Concurrent or previous endocrine disorders (e.g.,hyperthyroidism, aberration in growth&#xD;
             hormone)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Kantou</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plasma concentration</keyword>
  <keyword>ASP7991</keyword>
  <keyword>food effect</keyword>
  <keyword>PTH (parathyroid hormone)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ASP7991</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01675518
org study id: 7991-CL-0001
nct id: NCT01675518
lead sponsor: 
has dmc: No
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics
      of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is
      administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991
      in fasted and fed conditions are compared.
This study consists of two parts. In Part 1, the study will begin as a single rising dose
      escalation design under randomized double-blind and fasting conditions. In each dose group,
      volunteers will be randomized to receive an oral administration of either active drug
      (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.

      Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to
      volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
time frame: for 96 hours after dosing
measure: Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F
time frame: for 96 hours after dosing
description: Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
measure: Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr
time frame: for 96 hour after dosing
description: Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours
measure: plasma parathyroid hormon concentration
time frame: for 96 hours after dosing
description: Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
arm group label: Part-1 dose 1
arm group type: Experimental
arm group label: Part-1 dose 2
arm group type: Experimental
arm group label: Part-1 dose 3
arm group type: Experimental
arm group label: Part-1 dose 4
arm group type: Experimental
arm group label: Part-1 dose 5
arm group type: Experimental
arm group label: Part-1 dose 6
arm group type: Experimental
arm group label: Part-1 placebo
arm group type: Placebo Comparator
arm group label: Part-2 fed
arm group type: Experimental
arm group label: Part-2 fasted
arm group type: Experimental
intervention type: Drug
intervention name: ASP7991
description: oral
arm group label: Part-1 dose 1
arm group label: Part-1 dose 2
arm group label: Part-1 dose 3
arm group label: Part-1 dose 4
arm group label: Part-1 dose 5
arm group label: Part-1 dose 6
arm group label: Part-2 fasted
arm group label: Part-2 fed
intervention type: Drug
intervention name: Placebo
description: oral
arm group label: Part-1 placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
country: Japan
responsible party type: Sponsor
mesh term: ASP7991