<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/NCT02195635</url>
  </required_header>
  <id_info>
    <org_study_id>LX1606.1-109-NRM</org_study_id>
    <secondary_id>LX1606.109</secondary_id>
    <nct_id>NCT02195635</nct_id>
  </id_info>
  <brief_title>Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lexicon Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lexicon Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the&#xD;
      pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to&#xD;
      administration of single-dose telotristat etiprate in healthy male and female subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">October 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of telotristat ethyl</measure>
    <time_frame>Days 1, 2, 3, 6, 7, 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of metabolite LP-778902</measure>
    <time_frame>Days 1, 2, 3, 6, 7, 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of treatment-emergent adverse events</measure>
    <time_frame>Up to 39 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Drug Interactions</condition>
  <arm_group>
    <arm_group_label>Period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 500 mg telotristat etiprate on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telotristat etiprate</intervention_name>
    <description>500 mg telotristat etiprate</description>
    <arm_group_label>Period 1</arm_group_label>
    <arm_group_label>Period 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide acetate</intervention_name>
    <description>200 µg octreotide acetate three times daily</description>
    <arm_group_label>Period 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females ≥18 to ≤55 years of age&#xD;
&#xD;
          -  Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening&#xD;
&#xD;
          -  Vital signs (after at least 5 minutes resting in a supine position) at Screening that&#xD;
             are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic&#xD;
             blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm)&#xD;
&#xD;
          -  Willing to adhere to the prohibitions and restrictions specified in this protocol&#xD;
&#xD;
          -  Able to comprehend and willing to sign an Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of clinically significant physical, laboratory, or electrocardiogram (ECG)&#xD;
             findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator&#xD;
             and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study&#xD;
             conduct or interpretation of results&#xD;
&#xD;
          -  Use of any medications (prescription or over-the-counter), herbal tea, energy drinks,&#xD;
             herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or&#xD;
             supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose&#xD;
             administration and throughout the duration of the study, with the exception of those&#xD;
             approved by the Investigator and/or the Sponsor or Sponsor's representative&#xD;
&#xD;
          -  Prior exposure to telotristat etiprate&#xD;
&#xD;
          -  Use of tobacco, smoking cessation products, or products containing nicotine within 3&#xD;
             months prior to Screening and for the duration of the study&#xD;
&#xD;
          -  History of any major surgery within 6 months prior to Screening&#xD;
&#xD;
          -  History of renal disease&#xD;
&#xD;
          -  History of hepatic disease, or significantly abnormal liver function tests (&gt;1.5 x&#xD;
             upper limit of normal [ULN])&#xD;
&#xD;
          -  History of gall bladder abnormalities&#xD;
&#xD;
          -  History of any endocrine disorder&#xD;
&#xD;
          -  History of alcohol or substance abuse within 2 years prior to Screening&#xD;
&#xD;
          -  Positive urine screen for drugs of abuse and cotinine&#xD;
&#xD;
          -  Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea,&#xD;
             chocolate) within 72 hours prior to Check-in&#xD;
&#xD;
          -  Consumption of alcohol within 48 hours prior to Check in&#xD;
&#xD;
          -  Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange&#xD;
             containing products within 72 hours prior to Check in&#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>Suman Wason, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lexicon Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
  </intervention_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/NCT02195635
org study id: LX1606.1-109-NRM
secondary id: LX1606.109
nct id: NCT02195635
lead sponsor: 
has dmc: No
To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the
      pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to
      administration of single-dose telotristat etiprate in healthy male and female subjects
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of telotristat ethyl
time frame: Days 1, 2, 3, 6, 7, 8
measure: Plasma concentrations of metabolite LP-778902
time frame: Days 1, 2, 3, 6, 7, 8
measure: Number of treatment-emergent adverse events
time frame: Up to 39 days
arm group label: Period 1
arm group type: Experimental
description: Single oral dose of 500 mg telotristat etiprate on Day 1
arm group label: Period 2
arm group type: Other
description: Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6
intervention type: Drug
intervention name: Telotristat etiprate
description: 500 mg telotristat etiprate
arm group label: Period 1
arm group label: Period 2
intervention type: Drug
intervention name: Octreotide acetate
description: 200 µg octreotide acetate three times daily
arm group label: Period 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suman Wason, MD
role: Study Director
affiliation: Lexicon Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Octreotide