<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/NCT03798912</url>
  </required_header>
  <id_info>
    <org_study_id>TST-0114</org_study_id>
    <nct_id>NCT03798912</nct_id>
  </id_info>
  <brief_title>A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform</brief_title>
  <acronym>RaniPill</acronym>
  <official_title>A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RANI Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RANI Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to ascertain the safety, tolerability and performance of the&#xD;
      RaniPill capsule in healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The RaniPill device is capsule-like ingestible device, which injects a microneedle containing&#xD;
      a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human)&#xD;
      open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®)&#xD;
      will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in&#xD;
      additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg&#xD;
      of octreotide. The bioavailability of octreotide will be determined by serial blood sampling&#xD;
      in Groups A and B. Performance of the RaniPill will be evaluated in all groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2019</start_date>
  <completion_date type="Actual">February 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 17, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Healthy men and women volunteers</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and kind of adverse events possibly related to the RaniPill capsule</measure>
    <time_frame>Up to 30 days after ingestion of the device</time_frame>
    <description>All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic profile of octreotide delivered by the RaniPill capsule</measure>
    <time_frame>4 to 8 hours</time_frame>
    <description>Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmation of the excretion of all RaniPill device components</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Stool examinations to verify that all components of the RaniPill capsule have been defecated</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Intravenous octreotide group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RaniPill A group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RaniPill B group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RaniPill C group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>RaniPill capsule containing octreotide</intervention_name>
    <description>Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.</description>
    <arm_group_label>Intravenous octreotide group</arm_group_label>
    <arm_group_label>RaniPill A group</arm_group_label>
    <arm_group_label>RaniPill B group</arm_group_label>
    <arm_group_label>RaniPill C group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent form&#xD;
&#xD;
          -  Willing to comply with all study procedures and available for the entire duration of&#xD;
             the study&#xD;
&#xD;
          -  Age between 18 and 55 years&#xD;
&#xD;
          -  BMI 17 - 32 kg/m2&#xD;
&#xD;
          -  In good general health confirmed by medical history, physical examination, and absence&#xD;
             of clinically important laboratory abnormalities per investigator's judgment;&#xD;
&#xD;
          -  Women of reproductive potential must use, between study day and the final study visit,&#xD;
             a highly effective contraceptive, as defined in the Informed Consent Document, and&#xD;
             have a negative urine pregnancy test at the time of screening, as well as on the day&#xD;
             of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to swallow an intact 000 capsule with water&#xD;
&#xD;
          -  History of gastrointestinal surgery or illness, including diarrhea, constipation or&#xD;
             other manifestations suggestive of abnormal digestion&#xD;
&#xD;
          -  Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5&#xD;
             days of study day&#xD;
&#xD;
          -  Barium ingestion within 30 days of study day&#xD;
&#xD;
          -  Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex&#xD;
&#xD;
          -  History chronic disease other than mild to moderate systemic hypertension&#xD;
&#xD;
          -  Menstruation on day of dosing&#xD;
&#xD;
          -  Pregnancy or lactating state&#xD;
&#xD;
          -  Participation in an investigational or marketed drug trial within 30 days of the&#xD;
             screening visit&#xD;
&#xD;
          -  Low likelihood, in the investigator's judgment, to complete the study as required per&#xD;
             study plan;&#xD;
&#xD;
          -  Any other history which, in the investigator's judgment, makes the subject ineligible&#xD;
             or exposes the subject to a risk;&#xD;
&#xD;
          -  History of allergic reactions to a component of the RaniPill device or any allergic&#xD;
             history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;&#xD;
&#xD;
          -  Febrile illness within 5 days;&#xD;
&#xD;
          -  History of drug or alcohol abuse or any other factor that, in the investigator's&#xD;
             opinion, may interfere with the subject's ability to cooperate and comply with the&#xD;
             study procedures.&#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>Arvinder K Dhalla, PhD</last_name>
    <role>Study Director</role>
    <affiliation>RANI Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RaniPill capsule, drug delivery, octreotide, pharmacokinetic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</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/NCT03798912
org study id: TST-0114
nct id: NCT03798912
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective of this study is to ascertain the safety, tolerability and performance of the
      RaniPill capsule in healthy volunteers
The RaniPill device is capsule-like ingestible device, which injects a microneedle containing
      a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human)
      open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®)
      will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in
      additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg
      of octreotide. The bioavailability of octreotide will be determined by serial blood sampling
      in Groups A and B. Performance of the RaniPill will be evaluated in all groups.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Healthy men and women volunteers
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and kind of adverse events possibly related to the RaniPill capsule
time frame: Up to 30 days after ingestion of the device
description: All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded
measure: Pharmacokinetic profile of octreotide delivered by the RaniPill capsule
time frame: 4 to 8 hours
description: Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill
measure: Confirmation of the excretion of all RaniPill device components
time frame: up to 7 days
description: Stool examinations to verify that all components of the RaniPill capsule have been defecated
arm group label: Intravenous octreotide group
arm group type: Active Comparator
description: Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis
arm group label: RaniPill A group
arm group type: Experimental
description: In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis
arm group label: RaniPill B group
arm group type: Experimental
description: In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis
arm group label: RaniPill C group
arm group type: Experimental
description: In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug
intervention type: Combination Product
intervention name: RaniPill capsule containing octreotide
description: Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
arm group label: Intravenous octreotide group
arm group label: RaniPill A group
arm group label: RaniPill B group
arm group label: RaniPill C group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arvinder K Dhalla, PhD
role: Study Director
affiliation: RANI Therapeutics
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Octreotide
sharing ipd: No