xml: <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/NCT05983939</url>
    </required_header>
    <id_info>
      <org_study_id>PTI-791-101</org_study_id>
      <nct_id>NCT05983939</nct_id>
    </id_info>
    <brief_title>Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers</brief_title>
    <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE_791 and Food Effect in Normal Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pipeline Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pipeline Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD),&#xD;
        Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a&#xD;
        fed state. Safety will be assessed by periodic measurement of vital signs, physical&#xD;
        examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events&#xD;
        (AE).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple&#xD;
        escalating doses in normal healthy subjects. The study will be conducted in three parts: Part&#xD;
        1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total&#xD;
        duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling&#xD;
        approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD&#xD;
        cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791,&#xD;
        enrolling approximately 8 subjects for a duration of 6 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>All roles are masked with the exception of the pharmacist/dose preparer.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Safety: Treatment-Emergent Adverse Events (TEAE)</measure>
      <time_frame>Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts</time_frame>
      <description>Number of participants with TEAEs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)</measure>
      <time_frame>Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts</time_frame>
      <description>Change in mean QTcF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK): Blood concentration levels of PIPE-791</measure>
      <time_frame>Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics: Urine concentration levels of PIPE-791</measure>
      <time_frame>Baseline on day 1 through day 2 for SAD cohorts and from baseline on day 1 through day 7 for MAD cohorts</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>PIPE-791</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PIPE-791</intervention_name>
      <description>Single and multiple ascending oral doses of PIPE-791 tablets.</description>
      <arm_group_label>PIPE-791</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Single and multiple ascending oral doses of matching placebo tablets.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female between 18 and 55 years of age (inclusive) at the time of signing&#xD;
               informed consent.&#xD;
  &#xD;
            -  Male or female subjects with reproductive potential agree to comply with&#xD;
               protocol-approved double barrier contraceptive method 30 days prior to the first dose&#xD;
               and up to 90 days post last dose.&#xD;
  &#xD;
            -  Medically healthy with no clinically significant or relevant abnormalities in medical&#xD;
               history, physical exam, vital signs, electrocardiogram (ECG), or laboratory&#xD;
               evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigatory.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a current or recurrent disease that could affect the investigational medicinal&#xD;
               product or affect clinical or laboratory assessments.&#xD;
  &#xD;
            -  Experienced a significant systemic illness, as judged by the Investigator, within 30&#xD;
               days of the first dose.&#xD;
  &#xD;
            -  Has a history of a significant medical, including hepatic and/or renal disease as&#xD;
               outlined in the protocol, or psychiatric disorder that may require treatment or make&#xD;
               the participant unlikely to fully complete the study or increase risk to the&#xD;
               participant.&#xD;
  &#xD;
            -  History of alcohol or other substance abuse within the 12 months prior to the dosing&#xD;
               at the discretion of the Investigator.&#xD;
  &#xD;
            -  Routine alcohol consumption meeting or exceeding protocol limits.&#xD;
  &#xD;
            -  History of prior malignancy (except adequately treated non-melanoma skin cancer,&#xD;
               carcinoma in-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized&#xD;
               prostate cancer).&#xD;
  &#xD;
            -  Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days&#xD;
               prior to Screening.&#xD;
  &#xD;
            -  Received an investigational agent within the last 30 days, prior to screening, or five&#xD;
               half-lives of the prior investigational agent.&#xD;
  &#xD;
            -  Use of any prescription medication, over-the-counter medication, vitamin or&#xD;
               supplement, herbal or homeopathic preparation within 7 days or 5 half-lives prior to&#xD;
               study drug administration, as determined by the Investigator. Hormone replacement&#xD;
               therapy and hormonal contraception is permissible throughout the study.&#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>Stephen Huhn, MD</last_name>
      <role>Study Director</role>
      <affiliation>Pipeline Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jules Lee</last_name>
      <phone>415-819-0405</phone>
      <email>jlee@pipeline-tx.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julie Iwashita</last_name>
      <phone>650-813-9981</phone>
      <email>jiwashita@pipeline-tx.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Worldwide Clinical Trials</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78217</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <phone>210-635-1515</phone>
        <email>participate@worldwide.com</email>
      </contact>
      <investigator>
        <last_name>Ellen Remenchik, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Multiple Sclerosis</keyword>
    <keyword>PIPE-791</keyword>
    <keyword>Health volunteers</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983939
  org study id: PTI-791-101
  nct id: NCT05983939
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD),
        Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a
        fed state. Safety will be assessed by periodic measurement of vital signs, physical
        examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events
        (AE).
  This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple
        escalating doses in normal healthy subjects. The study will be conducted in three parts: Part
        1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total
        duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling
        approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD
        cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791,
        enrolling approximately 8 subjects for a duration of 6 weeks.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: All roles are masked with the exception of the pharmacist/dose preparer.
  measure: Safety: Treatment-Emergent Adverse Events (TEAE)
  time frame: Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
  description: Number of participants with TEAEs
  measure: Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
  time frame: Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
  description: Change in mean QTcF
  measure: Pharmacokinetics (PK): Blood concentration levels of PIPE-791
  time frame: Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
  measure: Pharmacokinetics: Urine concentration levels of PIPE-791
  time frame: Baseline on day 1 through day 2 for SAD cohorts and from baseline on day 1 through day 7 for MAD cohorts
  arm group label: PIPE-791
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: PIPE-791
  description: Single and multiple ascending oral doses of PIPE-791 tablets.
  arm group label: PIPE-791
  intervention type: Drug
  intervention name: Placebo
  description: Single and multiple ascending oral doses of matching placebo tablets.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stephen Huhn, MD
  role: Study Director
  affiliation: Pipeline Therapeutics
  last name: Jules Lee
  phone: 415-819-0405
  email: jlee@pipeline-tx.com
  last name: Julie Iwashita
  phone: 650-813-9981
  email: jiwashita@pipeline-tx.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: No