<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/NCT03302845</url>
  </required_header>
  <id_info>
    <org_study_id>LX1606.1-110-NRM</org_study_id>
    <secondary_id>LX1606.110</secondary_id>
    <nct_id>NCT03302845</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Parallel Group, Drug-drug Pharmacokinetic Interaction Study to Evaluate the Effects of Multiple-dose Omeprazole and Famotidine on the Absorption of Single-dose Telotristat Ethyl 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This drug-drug interaction study will evaluate the impact of two different acid reducing&#xD;
      agents (from two different drug classes) co-administered with a single dose of telotristat&#xD;
      ethyl.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">November 7, 2017</completion_date>
  <primary_completion_date type="Actual">October 23, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed concentration of telotristat ethyl</measure>
    <time_frame>7 days</time_frame>
    <description>Maximum observed concentration of telotristat ethyl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum observed concentration of telotristat ethyl</measure>
    <time_frame>7 days</time_frame>
    <description>Time of maximum observed concentration of telotristat ethyl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl</measure>
    <time_frame>7 days</time_frame>
    <description>Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Up to 13 days</time_frame>
    <description>Number of adverse events throughout the duration of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Drug-drug Interaction</condition>
  <arm_group>
    <arm_group_label>Omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one 40 mg omeprazole capsule per day for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Famotidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one 40 mg famotidine tablet given twice daily for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole 40 MG</intervention_name>
    <description>Omeprazole 40 mg capsule</description>
    <arm_group_label>Omeprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famotidine 40 mg</intervention_name>
    <description>Famotidine 40 mg tablet</description>
    <arm_group_label>Famotidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telotristat ethyl 250 mg</intervention_name>
    <description>Telotristat ethyl 250 mg tablet</description>
    <arm_group_label>Famotidine</arm_group_label>
    <arm_group_label>Omeprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult males or females ≥18 to ≤ 65 years of age at the time of Screening:&#xD;
&#xD;
               1. Females of non-childbearing potential are to be surgically sterile (documented&#xD;
                  hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or&#xD;
                  postmenopausal (defined as at least 12 months of spontaneous amenorrhea). Females&#xD;
                  of childbearing potential must agree to use an adequate method of contraception&#xD;
                  during the study from CRU admission through Safety Follow-up. Adequate methods of&#xD;
                  contraception for subjects or partner include condom, diaphragm, or cervical cap&#xD;
                  used in conjunction with spermicidal gel, foam, cream, film, or suppository.&#xD;
                  Hormonal contraception is NOT acceptable in this study. If necessary,&#xD;
                  follicle-stimulating hormone (FSH) results &gt;40 IU/L at Screening are confirmatory&#xD;
                  in the absence of a clear postmenopausal history.&#xD;
&#xD;
               2. Nonsterile male subjects with sexual partners of childbearing potential must&#xD;
                  agree to use adequate methods of contraception from CRU admission through Safety&#xD;
                  Follow-up. Adequate methods of contraception for subjects or partner include the&#xD;
                  following: condom with spermicidal gel, diaphragm with spermicidal gel, coil&#xD;
                  (intrauterine device), surgical sterilization, vasectomy, oral contraceptive&#xD;
                  pill, depo-progesterone injections, progesterone implant (ie, Implanon®),&#xD;
                  NuvaRing®, Ortho Evra®; if a subject is not sexually active, but becomes active,&#xD;
                  he or his partner should use medically accepted forms of contraception.&#xD;
&#xD;
          -  Body mass index ≥18.0 to ≤32.0 kg/m2 at Screening and Baseline/predose Day 1&#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 (ICF)&#xD;
&#xD;
          -  All laboratory values at Screening and CRU admission fall within normal range or are&#xD;
             evaluated as not clinically significant (NCS) by the Investigator if outside normal&#xD;
             range.&#xD;
&#xD;
          -  Has no clinically meaningful abnormal findings during Screening and CRU admission&#xD;
             physical examination, Screening and Baseline ECG, or Screening and Baseline vital&#xD;
             signs&#xD;
&#xD;
          -  Has the ability to understand and communicate the requirements of the study and is&#xD;
             willing to comply with all study procedures&#xD;
&#xD;
          -  Has not consumed and agrees to abstain from taking any dietary supplements, herbal&#xD;
             products (eg, St. John's wort, garlic, or milk thistle), over-the-counter medications&#xD;
             (OTC), supratherapeutic doses of vitamins, or prescription drugs (except as authorized&#xD;
             by the Investigator AND Medical Monitor) from 14 days prior to CRU admission through&#xD;
             the Safety Follow-up Visit&#xD;
&#xD;
          -  Has not consumed alcohol-containing beverages for 3 days prior to CRU admission (as&#xD;
             confirmed by alcohol breath analyzer) and agrees not to consume alcohol through the&#xD;
             Safety Follow-up Visit&#xD;
&#xD;
          -  Has not used tobacco- and/or nicotine-containing products within 60 days prior to the&#xD;
             CRU admission and agrees to abstain from using tobacco- and/or nicotine-containing&#xD;
             products, including e-cigarettes, through the Safety Follow-up Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any clinically significant psychiatric, renal, hepatic, pancreatic,&#xD;
             cardiovascular, neurological, endocrinologic, hematological, or gastrointestinal (GI)&#xD;
             abnormality&#xD;
&#xD;
          -  Participation in another investigational study within 30 days of CRU admission&#xD;
&#xD;
          -  Receipt of any protein- or antibody-based therapeutic agents (eg, growth hormones or&#xD;
             monoclonal antibodies) within 3 months prior to Screening. Note: Influenza vaccine&#xD;
             will be allowed if administered &gt;21 days prior to CRU admission.&#xD;
&#xD;
          -  Prior exposure to TE&#xD;
&#xD;
          -  History of any serious adverse reaction or hypersensitivity to any inactive component&#xD;
             of TE (ie, microcrystalline cellulose, croscarmellose sodium [disintegrant], talc,&#xD;
             silicone dioxide, and magnesium stearate [non-bovine]), unless reaction is deemed&#xD;
             irrelevant to the study by the Investigator and Sponsor&#xD;
&#xD;
          -  History of malabsorption, bariatric surgery, gastric surgery, cholecystectomy,&#xD;
             short-bowel syndrome, or GI surgery that may induce malabsorption&#xD;
&#xD;
          -  History of any serious adverse reaction or hypersensitivity to any component of OMP or&#xD;
             FTE&#xD;
&#xD;
          -  History of any active infection within 14 days prior to first drug administration, if&#xD;
             deemed clinically significant by the Investigator and/or Sponsor&#xD;
&#xD;
          -  Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus&#xD;
             antibody) or positive human immunodeficiency virus antibody screens&#xD;
&#xD;
          -  Existence of any surgical or medical condition that, in the judgment of the&#xD;
             Investigator, might interfere with the absorption, distribution, metabolism, or&#xD;
             excretion of TE (appendectomy and hernia repair are acceptable)&#xD;
&#xD;
          -  Concurrent conditions that could interfere with safety and/or tolerability&#xD;
             measurements&#xD;
&#xD;
          -  Subject has donated plasma within 7 days of first drug administration.&#xD;
&#xD;
          -  Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days&#xD;
             prior to first drug administration.&#xD;
&#xD;
          -  Women who are breastfeeding or are planning to become pregnant during the study&#xD;
&#xD;
          -  eGFR ≤ 89 ml/min/1.73 m2&#xD;
&#xD;
          -  Positive pregnancy test (females only)&#xD;
&#xD;
          -  Positive urine screen for selected drugs of abuse and cotinine at Screening or CRU&#xD;
             admission&#xD;
&#xD;
          -  Consumption of caffeine- and/or xanthine-containing products (cola, coffee, tea,&#xD;
             chocolate, etc.) within 72 hours prior to CRU admission (Day 0) and throughout the&#xD;
             study&#xD;
&#xD;
          -  Consumption of grapefruit, Seville oranges, and grapefruit- or Seville&#xD;
             orange-containing products within 72 hours prior to CRU admission (Day 0) and&#xD;
             throughout the study&#xD;
&#xD;
          -  Need for dietary restrictions, unless the restrictions are approved by the&#xD;
             Investigator and Sponsor&#xD;
&#xD;
          -  Inability or difficulty swallowing whole tablets&#xD;
&#xD;
          -  Poor venous access as defined by the Investigator or a designee&#xD;
&#xD;
          -  Any other condition that compromises the ability of the subject to provide informed&#xD;
             consent or to comply with the objectives and procedures of this protocol, as judged by&#xD;
             the Investigator or medical monitor&#xD;
&#xD;
          -  Unable or unwilling to communicate or cooperate with the Investigator for any reason&#xD;
&#xD;
          -  Employee of the Investigator or study center, with direct involvement in the proposed&#xD;
             study or other studies under the direction of that Investigator or study center, as&#xD;
             well as family members of the employees or the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Covance Clinical Research Unit</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2018</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>Omeprazole</mesh_term>
    <mesh_term>Famotidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03302845
org study id: LX1606.1-110-NRM
secondary id: LX1606.110
nct id: NCT03302845
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This drug-drug interaction study will evaluate the impact of two different acid reducing
      agents (from two different drug classes) co-administered with a single dose of telotristat
      ethyl.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum observed concentration of telotristat ethyl
time frame: 7 days
description: Maximum observed concentration of telotristat ethyl
measure: Time of maximum observed concentration of telotristat ethyl
time frame: 7 days
description: Time of maximum observed concentration of telotristat ethyl
measure: Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
time frame: 7 days
description: Area under the plasma concentration-time curve beginning from the first dose until the last quantifiable concentration of telotristat ethyl
measure: Number of adverse events
time frame: Up to 13 days
description: Number of adverse events throughout the duration of the study
arm group label: Omeprazole
arm group type: Experimental
description: Subjects will receive one 40 mg omeprazole capsule per day for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions.
arm group label: Famotidine
arm group type: Experimental
description: Subjects will receive one 40 mg famotidine tablet given twice daily for 4 days and one 250 mg telotristat ethyl tablet on two separate occasions.
intervention type: Drug
intervention name: Omeprazole 40 MG
description: Omeprazole 40 mg capsule
arm group label: Omeprazole
intervention type: Drug
intervention name: Famotidine 40 mg
description: Famotidine 40 mg tablet
arm group label: Famotidine
intervention type: Drug
intervention name: Telotristat ethyl 250 mg
description: Telotristat ethyl 250 mg tablet
arm group label: Famotidine
arm group label: Omeprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 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: Omeprazole
mesh term: Famotidine
sharing ipd: Undecided