<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/NCT01691924</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-PBF-2012-38</org_study_id>
    <nct_id>NCT01691924</nct_id>
  </id_info>
  <brief_title>Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers</brief_title>
  <official_title>Randomized, Double Blind, Placebo Controlled &quot;First In-human&quot; Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palo Biofarma, S.L</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      No clinical trials with PBF-509 in humans have been performed to date. Only preclinical&#xD;
      studies have been done to assess the pharmacology and pharmacokinetics, the safety and the&#xD;
      toxicological profile of the PBF-509.&#xD;
&#xD;
      An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical&#xD;
      trial where a single oral, dose-escalating, and placebo-controlled design will be&#xD;
      implemented.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>5-7 days post-dose</time_frame>
    <description>Safety and Tolerability evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic profile analysis</measure>
    <time_frame>0-24 h post dose</time_frame>
    <description>pre-dose; 10; 20; 30; 40; 50; 60; 75 minutes; 1.5h; 2; 2.5; 3; 3.5; 4; 8; 12; 16; 24 hours postdose administration and after recording vital signs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules: solid microcrystalline cellulose c.s.p</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-509</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBF-509</intervention_name>
    <arm_group_label>PBF-509</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each subject must meet all of the following inclusion criteria at the pre-study&#xD;
             screening visit (within 4 weeks prior to dosing) in order to participate in this&#xD;
             study.&#xD;
&#xD;
          -  Healthy male subjects, 18-45 years of age.&#xD;
&#xD;
          -  Clinically acceptable blood pressure and pulse rate in supine and standing position.&#xD;
             Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.&#xD;
&#xD;
          -  Body weight within normal range (Quetelet's index between 19 and 26) expressed as&#xD;
             weight (kg) / height (m2)..&#xD;
&#xD;
          -  Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine&#xD;
             patches, etc., for 6 months prior to the administration of the study medication).&#xD;
&#xD;
          -  Able to understand the nature of the study and comply with all their requirements.&#xD;
&#xD;
          -  Free acceptance to participate in the study by obtains signed informed consent form&#xD;
             approved by the Ethics Committee of the Hospital (CEIC).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious adverse reactions or hypersensitivity to any drug.&#xD;
&#xD;
          -  Presence or history of allergies requiring acute or chronic treatment (except seasonal&#xD;
             allergic rhinitis).&#xD;
&#xD;
          -  Background or clinical evidence of chronic diseases.&#xD;
&#xD;
          -  Acute illness two weeks before drug administration.&#xD;
&#xD;
          -  Having undergone major surgery during the previous 6 months.&#xD;
&#xD;
          -  History of alcohol or drug abuse in the last 5 years.&#xD;
&#xD;
          -  Abnormal physical findings of clinical significance at the screening examination or&#xD;
             baseline which would interfere with the objectives of the study.&#xD;
&#xD;
          -  Need of any prescription medication within 14 days prior to the administration of the&#xD;
             drug and non prescription medication or herbal medicines within 7 days prior to the&#xD;
             administration of the drug.&#xD;
&#xD;
          -  Participation in other clinical trials during the previous 90 days in which an&#xD;
             investigational drug or a commercially available drug was tested.&#xD;
&#xD;
          -  Not having donated blood during 3 month period before inclusion in the study.&#xD;
&#xD;
          -  Existence of any surgical or medical condition which might interfere with the&#xD;
             absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or&#xD;
             hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of&#xD;
             pronounced constipation or diarrhea or conditions associated with total or partial&#xD;
             obstruction of the urinary tract.&#xD;
&#xD;
          -  12 lead ECG obtained at screening with PR &gt; 220 msec, QRS&gt;120 msec and QTc &gt;440 msec,&#xD;
             bradycardia (&lt;50 bpm) or clinically significant minor ST wave changes or any other&#xD;
             abnormal changes on the screening ECG.&#xD;
&#xD;
          -  Symptoms of a significant somatic or mental illness in the four week period preceding&#xD;
             drug administration.&#xD;
&#xD;
          -  History of hepatitis B and / or C and / or positive serology results which indicate&#xD;
             the presence of hepatitis B and / or C.&#xD;
&#xD;
          -  Positive results from the HIV serology.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory values (as determined by the Principal&#xD;
             Investigator) at the screening evaluation.&#xD;
&#xD;
          -  Positive results of the drug screening the day before starting treatment period.&#xD;
&#xD;
          -  Known hypersensitivity to the study drug or the composition of the galenical form&#xD;
&#xD;
          -  History of psychiatric diseases or epileptic seizures&#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>Rosa M. Antonijoan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palobiofarma S.L. (molecule owner)</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08302</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cim- Sant Pau, HSCSP</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya/Barcelona</state>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>March 7, 2016</last_update_submitted>
  <last_update_submitted_qc>March 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenosine A2a receptor antagonist</keyword>
  <keyword>adenosine receptor modulator</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_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/NCT01691924
org study id: IIBSP-PBF-2012-38
nct id: NCT01691924
lead sponsor: 
collaborator: 
has dmc: No
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical
      studies have been done to assess the pharmacology and pharmacokinetics, the safety and the
      toxicological profile of the PBF-509.

      An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical
      trial where a single oral, dose-escalating, and placebo-controlled design will be
      implemented.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Number of Adverse Events
time frame: 5-7 days post-dose
description: Safety and Tolerability evaluation
measure: Pharmacokinetic profile analysis
time frame: 0-24 h post dose
description: pre-dose; 10; 20; 30; 40; 50; 60; 75 minutes; 1.5h; 2; 2.5; 3; 3.5; 4; 8; 12; 16; 24 hours postdose administration and after recording vital signs.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules: solid microcrystalline cellulose c.s.p
arm group label: PBF-509
arm group type: Experimental
description: The initial dose-escalation scheme includes the following eight doses: 10 mg, 20 mg, 40 mg,80 mg, 160 mg, 320 mg, 480 mg and 620 mg. This dose-escalation scheme has been built with the aim to reach the Minimum Intolerated Dose (MID), i.e. when investigator should stop escalating, and consequently the MTD.
intervention type: Drug
intervention name: PBF-509
arm group label: PBF-509
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa M. Antonijoan, MD
role: Principal Investigator
affiliation: Centre de Investigació de Medicaments. Hospital de la Santa Creu i Sant Pau
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Parkinson Disease