<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/NCT02262026</url>
  </required_header>
  <id_info>
    <org_study_id>1503015528</org_study_id>
    <nct_id>NCT02262026</nct_id>
  </id_info>
  <brief_title>The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism</brief_title>
  <official_title>A Phase One Study Investigating the Tolerability and Effects of AZD0530 on Functional Neuroimaging Responses in Individuals With or Without a Family History of Alcoholism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and&#xD;
      Pavlovian-to-instrumental transfer (PIT), part II Saracatinib&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the effect of oral AZ D0530 at various doses on neuroimaging parameters associated&#xD;
      with various forms of impulsivity mediated through glutamate-dopamine interactions, as&#xD;
      ascertained through functional magnetic resonance imaging. -- --NOTE-- AZD0530 dosage of 50mg&#xD;
      was discontinued by manufacturer. Adjustments were made to account for the removal of the&#xD;
      50mg dosage in all arms of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">April 26, 2019</completion_date>
  <primary_completion_date type="Actual">April 26, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BOLD activation during A1 phase</measure>
    <time_frame>4 Hours post medication administration</time_frame>
    <description>BOLD activation during the A1 phase of the MRI Monetary Incentive Delay task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BOLD signal activation in the anterior cingulate cortex(ACC)</measure>
    <time_frame>4 Hours post medication administration</time_frame>
    <description>BOLD signal activation in the anterior cingulate cortex (ACC) observed during False Alarms of the GoNoGo Task</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>FHP; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHP; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHP; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHP; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHP; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHP; placebo, then 125mg AZD0530,then 50mg AZD0530</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family History positive for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FHN; placebo, then 125mg AZD0530, then 50mg AZD0530</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family History negative for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>125 mg AZD0530</intervention_name>
    <description>Randomized to receive 125 mg of AZD0530</description>
    <arm_group_label>FHN; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 125mg AZD0530, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 125mg AZD0530,then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <other_name>saracatinib</other_name>
    <other_name>AZD0530</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50 mg AZD0530</intervention_name>
    <description>Randomized to receive 50 mg of AZD0530</description>
    <arm_group_label>FHN; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 125mg AZD0530, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 125mg AZD0530,then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <other_name>saracatinib</other_name>
    <other_name>AZD0530</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>FHN; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHN; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 125mg AZD0530, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHN; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then 50mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 125mg AZD0530, then placebo, then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then 125mg AZD0530, then placebo</arm_group_label>
    <arm_group_label>FHP; 50mg AZD0530, then placebo, then 125mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 125mg AZD0530,then 50mg AZD0530</arm_group_label>
    <arm_group_label>FHP; placebo, then 50mg AZD0530, then 125mg AZD0530</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clear History of a father having a history of alcoholism, OR a mother AND another 1st&#xD;
             or 2nd degree relative having a history of alcoholism, OR no 1st or 2nd degree&#xD;
             relatives with alcoholism or substance abuse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current diagnosis of DSM-IV-TR Axis I disorder, or past diagnosis of any substance use&#xD;
             disorder or moderate alcohol use disorder&#xD;
&#xD;
          2. Report of psychotic disorder in a 1º relative&#xD;
&#xD;
          3. Auditory or visual impairment that interferes with test taking&#xD;
&#xD;
          4. History of prenatal exposure to alcohol plus currently meeting criteria for features&#xD;
             of fetal alcohol syndrome&#xD;
&#xD;
          5. Not speaking English fluently or being a non-native English speaker, or being educated&#xD;
             in a primary language other than English &gt;grade 1&#xD;
&#xD;
          6. Mental retardation (Full Scale IQ&lt;70) using 2 WASI subtests for IQ estimate&#xD;
&#xD;
          7. Traumatic brain injury with loss of consciousness &gt; 30 minutes, or concussion in last&#xD;
             30 days&#xD;
&#xD;
          8. Presence or history of any medical/neurologic illness that may affect brain physiology&#xD;
             (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural&#xD;
             MRI (all structural scans are read by a licensed radiologist)&#xD;
&#xD;
          9. Current pregnancy (all females will be tested with urine screens on the day of MRI and&#xD;
             prior to each phase of drug treatment)&#xD;
&#xD;
         10. Positive urine screen for the presence of marijuana, cocaine, opiates or breath screen&#xD;
             to detect the presence of alcohol, administered at each lab visit.&#xD;
&#xD;
         11. Inability to comprehend the consent form appropriately&#xD;
&#xD;
         12. Ferromagnetic metal devices, clips or fragments in body (orbital x-ray performed if&#xD;
             needed).&#xD;
&#xD;
         13. Current use (within 30 days of screening) of specific psychoactive medications (e.g.,&#xD;
             typical neuroleptics, narcotic analgesics, antiparkinsonian medications, systemic&#xD;
             corticosteroids, or medications with significant central anticholinergic activity,&#xD;
             etc.). Current use of warfarin.&#xD;
&#xD;
         14. Current use of the following medications (CYP3A4 substrates whose metabolism may be&#xD;
             slowed by AZD0530): carbamazepine, colchicine, cyclosporine, disopyramide,&#xD;
             fluticasone, quinidine, vinblastine, vincristine, nifedipine. Patients taking&#xD;
             sildenafil, tadalafil, and vardenafil will be advised to stop taking these medications&#xD;
             for the duration of the trial. Patients cannot take the following drugs which inhibit&#xD;
             the CYP3A4 isoenzyme: cimetidine, cyclosporine, danazol, fluconazole, grapefruit&#xD;
             juice, HIV protease inhibitors, itraconazole, ketoconazole, macrolides, miconazole,&#xD;
             nefazodone, omeprazole, ritonavir, and verapamil, aromatase inhibitors, docetaxel&#xD;
&#xD;
         15. Neutropenia defined as absolute neutrophils count of &lt;1,500/microliter.&#xD;
&#xD;
         16. Thrombocytopenia defined as platelet count &lt;100x103/microliter.&#xD;
&#xD;
         17. AST, ALT, total bilirubin &gt;1.5 times upper normal; serum creatinine, &gt;2 time upper&#xD;
             normal limit, total bilirubin&gt;1.5 times ULN; Serum creatinine &gt;2.0 times ULN.&#xD;
&#xD;
         18. History of interstitial lung disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Godfrey D Pearlson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Saracatinib</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02262026/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02262026/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02262026
org study id: 1503015528
nct id: NCT02262026
lead sponsor: 
has dmc: Yes
Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and
      Pavlovian-to-instrumental transfer (PIT), part II Saracatinib
To assess the effect of oral AZ D0530 at various doses on neuroimaging parameters associated
      with various forms of impulsivity mediated through glutamate-dopamine interactions, as
      ascertained through functional magnetic resonance imaging. -- --NOTE-- AZD0530 dosage of 50mg
      was discontinued by manufacturer. Adjustments were made to account for the removal of the
      50mg dosage in all arms of the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: BOLD activation during A1 phase
time frame: 4 Hours post medication administration
description: BOLD activation during the A1 phase of the MRI Monetary Incentive Delay task
measure: BOLD signal activation in the anterior cingulate cortex(ACC)
time frame: 4 Hours post medication administration
description: BOLD signal activation in the anterior cingulate cortex (ACC) observed during False Alarms of the GoNoGo Task
arm group label: FHP; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test
arm group label: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test
arm group label: FHP; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
arm group label: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
arm group label: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test
arm group label: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530
arm group type: Experimental
description: Family History positive for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test
arm group label: FHN; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of 125 mg, then 50 mg, then placebo separated by 1 week for each test
arm group label: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of 125 mg, then placebo, then 50mg separated by 1 week for each test
arm group label: FHN; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of 50mg, then 125mg, then placebo separated by 1 week for each test
arm group label: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of 50mg, then placebo, then 125mg separated by 1 week for each test
arm group label: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of placebo, then 50 mg, then 125 mg separated by 1 week for each test
arm group label: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530
arm group type: Active Comparator
description: Family History negative for alcoholism will take place in blinded testing of placebo, then 125 mg, then 50 mg separated by 1 week for each test
intervention type: Drug
intervention name: 125 mg AZD0530
description: Randomized to receive 125 mg of AZD0530
arm group label: FHN; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHN; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530
arm group label: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530
arm group label: FHP; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHP; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530
arm group label: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530
other name: saracatinib
other name: AZD0530
intervention type: Drug
intervention name: 50 mg AZD0530
description: Randomized to receive 50 mg of AZD0530
arm group label: FHN; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHN; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530
arm group label: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530
arm group label: FHP; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHP; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530
arm group label: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530
other name: saracatinib
other name: AZD0530
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: FHN; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHN; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHN; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHN; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHN; placebo, then 125mg AZD0530, then 50mg AZD0530
arm group label: FHN; placebo, then 50mg AZD0530, then 125mg AZD0530
arm group label: FHP; 125mg AZD0530, then 50mg AZD0530, then placebo
arm group label: FHP; 125mg AZD0530, then placebo, then 50mg AZD0530
arm group label: FHP; 50mg AZD0530, then 125mg AZD0530, then placebo
arm group label: FHP; 50mg AZD0530, then placebo, then 125mg AZD0530
arm group label: FHP; placebo, then 125mg AZD0530,then 50mg AZD0530
arm group label: FHP; placebo, then 50mg AZD0530, then 125mg AZD0530
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Godfrey D Pearlson, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Saracatinib
provided document: 
provided document: 