<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/NCT03030105</url>
  </required_header>
  <id_info>
    <org_study_id>BPN14770-CNS-103</org_study_id>
    <nct_id>NCT03030105</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Single-dose, 6-Period Crossover Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tetra Discovery Partners</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tetra Discovery Partners</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to&#xD;
      evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive&#xD;
      impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and&#xD;
      additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 38 subjects will be enrolled into the study. The study duration will be up to 12&#xD;
      weeks with 6 weeks of single-dose Treatment Visits. The study will consist of a Screening&#xD;
      Visit (up to 28 days prior to first study drug administration), six inpatient Treatment&#xD;
      Visits (Periods 1 through 6), and a Follow-Up/Early Termination Visit (7-10 days after the&#xD;
      last dose of study medication). An additional study visit may be necessary to complete the&#xD;
      required cognitive test familiarization if not completed during the Screening Visit. Each&#xD;
      Treatment Visit will occur approximately one week apart, allowing a 6 to 8 day washout&#xD;
      period.&#xD;
&#xD;
      Subjects will be randomized to 1 of 6 treatment sequences based on a computer-generated&#xD;
      randomization schedule. Subjects will receive all 6 treatments as specified by the treatment&#xD;
      sequence according to a 6 × 6 Williams Latin square design. The following treatments will be&#xD;
      administered:&#xD;
&#xD;
      A. Scopolamine placebo + BPN14770 placebo + donepezil placebo&#xD;
&#xD;
      B. Scopolamine 0.5 mg + BPN14770 placebo + donepezil placebo&#xD;
&#xD;
      C. Scopolamine 0.5 mg + BPN14770 10 mg + donepezil placebo&#xD;
&#xD;
      D. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil placebo&#xD;
&#xD;
      E. Scopolamine 0.5 mg + donepezil 10 mg +BPN14770 placebo&#xD;
&#xD;
      F. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil 10 mg&#xD;
&#xD;
      During each of the Treatment Visits (Periods 1 through 6), subjects will be admitted to the&#xD;
      Clinical Research Unit (CRU) the day prior to each study drug administration (Day -1) and&#xD;
      discharged the day after study drug administration (Day 2). On the morning of study drug&#xD;
      administration (Day 1), subjects will be given study drug (BPN14770, donepezil, or placebo)&#xD;
      with 240mL of room temperature water 2 hours prior to the scopolamine or scopolamine placebo&#xD;
      sc injection. The timing for study drug administration will be referred to as t-2 (Hour -2).&#xD;
      Breakfast should be available approximately 30 minutes following the morning drug&#xD;
      administration. Two hours after study drug administration, the scopolamine or scopolamine&#xD;
      placebo sc injection will be administered. The time at which the scopolamine or scopolamine&#xD;
      placebo sc injection is administered will be referred to as t0 (Hour 0).&#xD;
&#xD;
      Cognitive testing will be performed 30 minutes prior to treatment with scopolamine injection&#xD;
      and at hours 1, 2, 3, 4, and 6 post-scopolamine injection.&#xD;
&#xD;
      PK samples will be collected during the treatment period to confirm study drug is present.&#xD;
&#xD;
      Safety assessments throughout the study will include physical exams, ECGs, vital signs,&#xD;
      chemistry, hematology, and urinalysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Groton Maze Learning Test (GMLT)</measure>
    <time_frame>2 hours post-scopolamine s.c. injection</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Detection Test (DET)</measure>
    <time_frame>30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>One Card Learning Test (OCL)</measure>
    <time_frame>30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>One Back Test (ONB)</measure>
    <time_frame>30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Two Back Test (TWOB)</measure>
    <time_frame>30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Physical exam, vital signs, clinical laboratory, ECG</measure>
    <time_frame>Study duration up to 12 weeks</time_frame>
    <description>To evaluate the safety and tolerability of BPN14770 in healthy subjects</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma concentrations of BPN14770</measure>
    <time_frame>Plasma BPN14770 concentrations at 0, 2.5, 4.5 and 6.5 hours post-scopolamine sc injection</time_frame>
    <description>To obtain pharmacokinetic data on BPN14770</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>A) P:P:P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Scopolamine placebo : BPN14770 placebo : Donepezil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B) S:P:P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Scopolamine 0.5mg : BPN14770 placebo : Donepezil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C) S:B:P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scopolamine 0.5mg : BPN14770 10mg : Donepezil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D) S:B:P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scopolamine 0.5mg : BPN14770 50mg : Donepezil placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E) S:P:D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Scopolamine 0.5mg : BPN14770 placebo : Donepezil 10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>F) S:B:D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scopolamine 0.5mg : BPN14770 50mg : Donepezil 10mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPN14770</intervention_name>
    <description>investigational drug</description>
    <arm_group_label>C) S:B:P</arm_group_label>
    <arm_group_label>D) S:B:P</arm_group_label>
    <arm_group_label>F) S:B:D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPN14770 placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>A) P:P:P</arm_group_label>
    <arm_group_label>B) S:P:P</arm_group_label>
    <arm_group_label>E) S:P:D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil</intervention_name>
    <description>comparator</description>
    <arm_group_label>E) S:P:D</arm_group_label>
    <arm_group_label>F) S:B:D</arm_group_label>
    <other_name>Aricept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>A) P:P:P</arm_group_label>
    <arm_group_label>B) S:P:P</arm_group_label>
    <arm_group_label>C) S:B:P</arm_group_label>
    <arm_group_label>D) S:B:P</arm_group_label>
    <other_name>Aricept placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Scopolamine 0.6 MG/ML</intervention_name>
    <description>cognition impairment</description>
    <arm_group_label>B) S:P:P</arm_group_label>
    <arm_group_label>C) S:B:P</arm_group_label>
    <arm_group_label>D) S:B:P</arm_group_label>
    <arm_group_label>E) S:P:D</arm_group_label>
    <arm_group_label>F) S:B:D</arm_group_label>
    <other_name>Hyoscine s.c.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Scopolamine placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>A) P:P:P</arm_group_label>
    <other_name>Hyoscine s.c. placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males or females between the ages of 18 to 55 years at Screening.&#xD;
&#xD;
          2. Body mass index between 18 kg/m2 to 33 kg/m2, inclusive, and body weight of &gt;50 kg&#xD;
             (110 pounds).&#xD;
&#xD;
          3. Female subjects must be surgically sterile (bilateral tubal ligation, hysterectomy, or&#xD;
             bilateral oophorectomy at least 6 months prior to first study drug administration), at&#xD;
             least two years post-menopausal, or willing to either (1) utilize hormonal&#xD;
             contraception plus use one barrier method or (2) use two barrier methods of&#xD;
             contraception from initial screening until one month after taking the final dose.&#xD;
             Barrier methods of contraception include diaphragm, cervical cap, male condom, female&#xD;
             condom, and spermicidal foam and sponges. An intrauterine device (IUD) is also&#xD;
             considered a barrier method of contraception in this study; if the subject is using an&#xD;
             IUD, she will need to use an additional barrier method of contraception. Menopausal&#xD;
             status will be verified by testing for follicle stimulating hormone (FSH ≥25 mIU/mL)&#xD;
             at Screening. In addition, all females must have a negative blood test for pregnancy&#xD;
             within 28 days during the Screening period and negative urine test for pregnancy on&#xD;
             Day-1 of each Treatment Visit regardless of childbearing potential.&#xD;
&#xD;
          4. Male subjects must be willing to inform female partners of their participation in the&#xD;
             study and must agree to use adequate contraceptive methods (vasectomy performed at&#xD;
             least 6 months prior to first study drug administration, or use at least one barrier&#xD;
             method of birth control).&#xD;
&#xD;
          5. Able to understand the study procedures, voluntarily consent to participate in this&#xD;
             study, and provide written informed consent prior to start of any study-specific&#xD;
             procedures.&#xD;
&#xD;
          6. Willing and able to remain in the study unit for the required periods and return for&#xD;
             each treatment of the six treatment periods, including the outpatient visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically significant abnormality, in the Investigator's judgement, in Screening&#xD;
             hematology, chemistry, or urinalysis tests, or from medical history, social history,&#xD;
             vital sign, or physical examination&#xD;
&#xD;
          2. Active liver disease or positive serology results for hepatitis B surface antigen&#xD;
             (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).&#xD;
&#xD;
          3. Abnormal liver function test at the Screening Visit (aspartate aminotransferase or&#xD;
             alanine aminotransferase &gt;2 × the upper limit of normal [ULN]; total bilirubin &gt;1.5 ×&#xD;
             ULN; or alkaline phosphatase &gt;2 × ULN based on appropriate age and gender normal&#xD;
             values).&#xD;
&#xD;
          4. Current or past history of angle closure glaucoma, or diagnosis of angle closure&#xD;
             glaucoma.&#xD;
&#xD;
          5. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or&#xD;
             hypertension (systolic BP ˃150 mmHg or diastolic BP ˃100 mmHg) based on sitting values&#xD;
             obtained. Out-of-range results may be repeated once at Screening. This exclusion&#xD;
             applies to the vital signs performed at Screening and on Day -1 on Treatment Period 1.&#xD;
&#xD;
          6. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate&#xD;
             ˃110 bpm) based on supine ECG values obtained. Out-of-range results may be repeated&#xD;
             once at Screening. This exclusion applies to the vital signs performed at Screening&#xD;
             and on Day -1 on Treatment Period 1.&#xD;
&#xD;
          7. Current or past history of significant (in the Investigator's judgement)&#xD;
             cardiovascular, cerebrovascular, pulmonary, renal, or liver disease. Stable,&#xD;
             well-controlled hypertension and hyperlipidemias are allowed.&#xD;
&#xD;
          8. Clinically important or significant conduction abnormalities on single ECG or evidence&#xD;
             or history of long QT syndrome based on supine ECG values obtained at Screening.&#xD;
             Out-of-range results may be repeated once at Screening.&#xD;
&#xD;
          9. Current or past history of gastric or duodenal ulcers or other diseases of the&#xD;
             gastrointestinal tract that could interfere with absorption of study drug. Note:&#xD;
             Subjects with a history of appendectomy or cholecystectomy may be enrolled.&#xD;
&#xD;
         10. Active acute or chronic infectious diseases.&#xD;
&#xD;
         11. Unable to discontinue medications including anticholinergic agents, psychotropic&#xD;
             drugs, sedative antihistamines, or other centrally active medications [e.g., CNS-&#xD;
             penetrant beta blockers], and moderate to strong inhibitors or inducers of CYP3A4,&#xD;
             CYP2D6, or other cytochromes) 14 days prior to the first dose of study drug (Period 1,&#xD;
             Day 1) and during the study (Follow-Up). Other prescription or non-prescription drugs&#xD;
             such as antihypertensive or cholesterol lowering drugs are allowed, if, in the&#xD;
             Investigator's judgement, they would not interfere with the study medication or the&#xD;
             cognitive testing.&#xD;
&#xD;
         12. Unable to discontinue and abstain from over-the-counter, herbal preparations, dietary&#xD;
             supplements, nutraceuticals, vitamins and minerals at least 7 days prior to the first&#xD;
             dose of study drug and during the study. The one exception to this rule is&#xD;
             acetaminophen, which may be taken for minor ailments at doses up to 1000 mg per day.&#xD;
&#xD;
         13. Any history of alcohol or other substance abuse, including marijuana, within the&#xD;
             previous year prior to the Screening visit (per the current edition of the Diagnostic&#xD;
             and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily)&#xD;
             consumption of alcohol exceeding two bottles of beer, or the equivalent amount of&#xD;
             other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled&#xD;
             spirits).&#xD;
&#xD;
         14. Any use of alcohol, grapefruit, marijuana, or other psychotropic agent within 12 hours&#xD;
             of admission into the CRU.&#xD;
&#xD;
         15. Active smokers or tobacco users (e.g., chew and snuff) who are unable to discontinue&#xD;
             tobacco use or nicotine-containing products (including e-cigarettes) at least 4 weeks&#xD;
             prior to Screening and to refrain from using during the study.&#xD;
&#xD;
         16. Inability or unwillingness to comply with the protocol or likely inability to complete&#xD;
             the study.&#xD;
&#xD;
         17. Participation in other clinical studies involving investigational drug within the&#xD;
             previous 30 days prior to the Screening Visit.&#xD;
&#xD;
         18. Donation of blood within the prior 4 weeks, or blood products within the prior 2&#xD;
             weeks, prior to first study drug administration.&#xD;
&#xD;
         19. Positive result for drugs of abuse, alcohol, or cotinine at Screening, or a positive&#xD;
             drug or alcohol (breath) result upon admission to CRU.&#xD;
&#xD;
         20. History of clinically significant drug allergy that includes symptoms such as&#xD;
             shortness of breath, rash, or edema. This includes known hypersensitivity to donepezil&#xD;
             hydrochloride, scopolamine, or belladonna, alkaloids.&#xD;
&#xD;
         21. Inability or unwillingness to perform the Cogstate cognitive function tests.&#xD;
&#xD;
         22. A suicidal ideation intensity score of 2 or higher per screening Columbia Suicide&#xD;
             Severity Rating Scale (C-SSRS) assessment and/or any suicidal behavior within the past&#xD;
             28 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cassandra Key, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICON Early Phase Services, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICON Early Phase Services, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognition</keyword>
  <keyword>Dementia</keyword>
  <keyword>Phosphodiesterase Type 4D</keyword>
  <keyword>PDE4D</keyword>
  <keyword>Scopolamine</keyword>
  <keyword>Donepezil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scopolamine</mesh_term>
    <mesh_term>Donepezil</mesh_term>
    <mesh_term>Butylscopolammonium Bromide</mesh_term>
    <mesh_term>BPN14770</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03030105
org study id: BPN14770-CNS-103
nct id: NCT03030105
lead sponsor: 
has dmc: No
This is a Phase 1, randomized, double-blind, placebo-controlled, 6-period crossover study to
      evaluate the effects of BPN14770 10 mg and 50 mg in reversing scopolamine-induced cognitive
      impairment in healthy volunteers. A positive control, donepezil 10 mg, will be included, and
      additivity of BPN14770 50 mg to donepezil 10 mg in reversing scopolamine effects will also be
      evaluated.
A total of 38 subjects will be enrolled into the study. The study duration will be up to 12
      weeks with 6 weeks of single-dose Treatment Visits. The study will consist of a Screening
      Visit (up to 28 days prior to first study drug administration), six inpatient Treatment
      Visits (Periods 1 through 6), and a Follow-Up/Early Termination Visit (7-10 days after the
      last dose of study medication). An additional study visit may be necessary to complete the
      required cognitive test familiarization if not completed during the Screening Visit. Each
      Treatment Visit will occur approximately one week apart, allowing a 6 to 8 day washout
      period.

      Subjects will be randomized to 1 of 6 treatment sequences based on a computer-generated
      randomization schedule. Subjects will receive all 6 treatments as specified by the treatment
      sequence according to a 6 × 6 Williams Latin square design. The following treatments will be
      administered:

      A. Scopolamine placebo + BPN14770 placebo + donepezil placebo

      B. Scopolamine 0.5 mg + BPN14770 placebo + donepezil placebo

      C. Scopolamine 0.5 mg + BPN14770 10 mg + donepezil placebo

      D. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil placebo

      E. Scopolamine 0.5 mg + donepezil 10 mg +BPN14770 placebo

      F. Scopolamine 0.5 mg + BPN14770 50 mg + donepezil 10 mg

      During each of the Treatment Visits (Periods 1 through 6), subjects will be admitted to the
      Clinical Research Unit (CRU) the day prior to each study drug administration (Day -1) and
      discharged the day after study drug administration (Day 2). On the morning of study drug
      administration (Day 1), subjects will be given study drug (BPN14770, donepezil, or placebo)
      with 240mL of room temperature water 2 hours prior to the scopolamine or scopolamine placebo
      sc injection. The timing for study drug administration will be referred to as t-2 (Hour -2).
      Breakfast should be available approximately 30 minutes following the morning drug
      administration. Two hours after study drug administration, the scopolamine or scopolamine
      placebo sc injection will be administered. The time at which the scopolamine or scopolamine
      placebo sc injection is administered will be referred to as t0 (Hour 0).

      Cognitive testing will be performed 30 minutes prior to treatment with scopolamine injection
      and at hours 1, 2, 3, 4, and 6 post-scopolamine injection.

      PK samples will be collected during the treatment period to confirm study drug is present.

      Safety assessments throughout the study will include physical exams, ECGs, vital signs,
      chemistry, hematology, and urinalysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Groton Maze Learning Test (GMLT)
time frame: 2 hours post-scopolamine s.c. injection
measure: Detection Test (DET)
time frame: 30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection
measure: One Card Learning Test (OCL)
time frame: 30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection
measure: One Back Test (ONB)
time frame: 30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection
measure: Two Back Test (TWOB)
time frame: 30 minutes prior and at 1, 2, 3, 4, and 6 hours post-scopolamine sc injection
measure: Physical exam, vital signs, clinical laboratory, ECG
time frame: Study duration up to 12 weeks
description: To evaluate the safety and tolerability of BPN14770 in healthy subjects
measure: Plasma concentrations of BPN14770
time frame: Plasma BPN14770 concentrations at 0, 2.5, 4.5 and 6.5 hours post-scopolamine sc injection
description: To obtain pharmacokinetic data on BPN14770
arm group label: A) P:P:P
arm group type: Placebo Comparator
description: Scopolamine placebo : BPN14770 placebo : Donepezil placebo
arm group label: B) S:P:P
arm group type: Placebo Comparator
description: Scopolamine 0.5mg : BPN14770 placebo : Donepezil placebo
arm group label: C) S:B:P
arm group type: Experimental
description: Scopolamine 0.5mg : BPN14770 10mg : Donepezil placebo
arm group label: D) S:B:P
arm group type: Experimental
description: Scopolamine 0.5mg : BPN14770 50mg : Donepezil placebo
arm group label: E) S:P:D
arm group type: Active Comparator
description: Scopolamine 0.5mg : BPN14770 placebo : Donepezil 10mg
arm group label: F) S:B:D
arm group type: Experimental
description: Scopolamine 0.5mg : BPN14770 50mg : Donepezil 10mg
intervention type: Drug
intervention name: BPN14770
description: investigational drug
arm group label: C) S:B:P
arm group label: D) S:B:P
arm group label: F) S:B:D
intervention type: Drug
intervention name: BPN14770 placebo
description: placebo
arm group label: A) P:P:P
arm group label: B) S:P:P
arm group label: E) S:P:D
intervention type: Drug
intervention name: Donepezil
description: comparator
arm group label: E) S:P:D
arm group label: F) S:B:D
other name: Aricept
intervention type: Drug
intervention name: Donepezil placebo
description: placebo
arm group label: A) P:P:P
arm group label: B) S:P:P
arm group label: C) S:B:P
arm group label: D) S:B:P
other name: Aricept placebo
intervention type: Drug
intervention name: Scopolamine 0.6 MG/ML
description: cognition impairment
arm group label: B) S:P:P
arm group label: C) S:B:P
arm group label: D) S:B:P
arm group label: E) S:P:D
arm group label: F) S:B:D
other name: Hyoscine s.c.
intervention type: Drug
intervention name: Scopolamine placebo
description: placebo
arm group label: A) P:P:P
other name: Hyoscine s.c. placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cassandra Key, MD
role: Principal Investigator
affiliation: ICON Early Phase Services, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
mesh term: Scopolamine
mesh term: Donepezil
mesh term: Butylscopolammonium Bromide
mesh term: BPN14770
sharing ipd: No