<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/NCT02208934</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-PBF-2014-28</org_study_id>
    <secondary_id>2014-002138-29</secondary_id>
    <nct_id>NCT02208934</nct_id>
  </id_info>
  <brief_title>Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers</brief_title>
  <official_title>Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg, 10 mg, 20 mg and 40 mg ) in Healthy Young Male 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>
      Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg,&#xD;
      10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>day 0 to day 7</time_frame>
    <description>Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Profile Analysis (Plasma concentrations)</measure>
    <time_frame>day 1</time_frame>
    <description>Baseline [pre-dose], [+ 10 min], [+ 20 min], [+ 40 min], [+ 60 min], [+ 1.5h], [+ 2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+ 8h], [+ 12h], [+16h] and [+ 24h] post-medication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Leeds Sleep Evaluation Questionnaire (LSEQ)</measure>
    <time_frame>baseline and +24h</time_frame>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Huntington's Disease</condition>
  <arm_group>
    <arm_group_label>PBF-999 (5 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg of PBF-999</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-999 (10 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg of PBF-999</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-999 (20 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg of PBF-999</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-999 (40 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg of PBF-999</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for the 5, 10, 20 and 40 mg dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBF-999</intervention_name>
    <description>5, 10, 20 and 40 mg of PBF-999</description>
    <arm_group_label>PBF-999 (10 mg)</arm_group_label>
    <arm_group_label>PBF-999 (20 mg)</arm_group_label>
    <arm_group_label>PBF-999 (40 mg)</arm_group_label>
    <arm_group_label>PBF-999 (5 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for all dosis of PBF-999</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.&#xD;
&#xD;
          2. Males should agree to abstain from sexual intercourse with a female partner or agree&#xD;
             to use a condom with spermicide, in addition to having their female partner use some&#xD;
             contraceptive measures until 28 days post-administration.&#xD;
&#xD;
          3. 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;
          4. Body weight within normal range (Quetelet's index between 19 and 26) expressed as&#xD;
             weight (kg) / height (m2).&#xD;
&#xD;
          5. Able to understand the nature of the study and comply with all their requirements.&#xD;
&#xD;
          6. 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;
          1. History of serious adverse reactions or hypersensitivity to any drug.&#xD;
&#xD;
          2. Presence or history of allergies requiring acute or chronic treatment (except seasonal&#xD;
             allergic rhinitis).&#xD;
&#xD;
          3. Background or clinical evidence of chronic diseases.&#xD;
&#xD;
          4. Acute illness two weeks before drug administration.&#xD;
&#xD;
          5. Having undergone major surgery during the previous 6 months.&#xD;
&#xD;
          6. 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;
          7. History of alcohol dependence or drug abuse in the last 5 years or daily consumption&#xD;
             of alcohol &gt; 40 g or high consumption of stimulating beverages (&gt; 5 coffees, teas or&#xD;
             coca cola drinks/ day).&#xD;
&#xD;
          8. Abnormal physical findings of clinical significance at the screening examination or&#xD;
             baseline which would interfere with the objectives of the study.&#xD;
&#xD;
          9. 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;
         10. 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;
         11. Having donated blood during 4 weeks period before inclusion in the study.&#xD;
&#xD;
         12. 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;
         13. 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440&#xD;
             msec, bradycardia (&lt;50 bpm) or clinically significant minor ST wave changes or any&#xD;
             other abnormal changes on the screening ECG that would interfere with measurement of&#xD;
             the QT interval.&#xD;
&#xD;
         14. Symptoms of a significant somatic or mental illness in the four week period preceding&#xD;
             drug administration.&#xD;
&#xD;
         15. History of hepatitis HBV and / or HCV and / or positive serology results which&#xD;
             indicate the presence of hepatitis B surface antigen and / or detectable HCV&#xD;
             ribonucleic acid (RNA).&#xD;
&#xD;
         16. Positive results from the HIV serology.&#xD;
&#xD;
         17. Clinically significant abnormal laboratory values (as determined by the Principal&#xD;
             Investigator) at the screening evaluation.&#xD;
&#xD;
         18. Positive results of the drugs at screening period or the day before starting treatment&#xD;
             period. A minimum list of 6 drugs will be screened for inclusion: Amphetamines,&#xD;
             Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be&#xD;
             repeated at the discretion of the Principal Investigator).&#xD;
&#xD;
         19. Known hypersensitivity to the study drug or the composition of the galenical form.&#xD;
&#xD;
         20. 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>Joan Martínez Colomer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIM Sant Pau - IIB 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 - IIB Sant Pau, HSCSP</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.iibsantpau.cat/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.palobiofarma.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</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>PDE10 inhibitor</keyword>
  <keyword>Huntington's disease</keyword>
  <keyword>phosphodiesterase 10 inhibitor</keyword>
  <keyword>psychiatric disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington 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/NCT02208934
org study id: IIBSP-PBF-2014-28
secondary id: 2014-002138-29
nct id: NCT02208934
lead sponsor: 
collaborator: 
has dmc: No
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 ( 5 mg,
      10 mg, 20 mg and 40 mg ) in Healthy Young Male Volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: day 0 to day 7
description: Vital Signs, ECG recordings, laboratory safety test and physical examination will be performed
measure: Pharmacokinetic Profile Analysis (Plasma concentrations)
time frame: day 1
description: Baseline [pre-dose], [+ 10 min], [+ 20 min], [+ 40 min], [+ 60 min], [+ 1.5h], [+ 2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+ 8h], [+ 12h], [+16h] and [+ 24h] post-medication
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
time frame: baseline and +24h
arm group label: PBF-999 (5 mg)
arm group type: Experimental
description: 5 mg of PBF-999
arm group label: PBF-999 (10 mg)
arm group type: Experimental
description: 10 mg of PBF-999
arm group label: PBF-999 (20 mg)
arm group type: Experimental
description: 20 mg of PBF-999
arm group label: PBF-999 (40 mg)
arm group type: Experimental
description: 40 mg of PBF-999
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for the 5, 10, 20 and 40 mg dose
intervention type: Drug
intervention name: PBF-999
description: 5, 10, 20 and 40 mg of PBF-999
arm group label: PBF-999 (10 mg)
arm group label: PBF-999 (20 mg)
arm group label: PBF-999 (40 mg)
arm group label: PBF-999 (5 mg)
intervention type: Drug
intervention name: Placebo
description: Placebo for all dosis of PBF-999
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joan Martínez Colomer, MD
role: Principal Investigator
affiliation: CIM Sant Pau - IIB Sant Pau
facility: 
facility: 
country: Spain
url: http://www.iibsantpau.cat/
description: Related Info
url: http://www.palobiofarma.com/
description: Related Info
responsible party type: Sponsor
mesh term: Huntington Disease