<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/NCT03832452</url>
  </required_header>
  <id_info>
    <org_study_id>ID-069-106</org_study_id>
    <secondary_id>2018-004546-42</secondary_id>
    <nct_id>NCT03832452</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function</brief_title>
  <official_title>Prospective, Single-center, Randomized, Double-blind, Placebo-controlled, Two-part Phase 1 Study to Assess the Effect of Single Therapeutic and Supra-therapeutic Doses of Lucerastat on the QT/QTc Interval Duration in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Idorsia Pharmaceuticals Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Idorsia Pharmaceuticals Ltd.</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>
      Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses&#xD;
      of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part&#xD;
      B: TQT study)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">April 22, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 2019</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>
    <intervention_model_description>Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)</measure>
    <time_frame>From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)</time_frame>
    <description>QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A: Treatment 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Treatment 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single oral dose of placebo on Day 1 and 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Treatment A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single oral dose of 400 mg moxifloxacin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of 1000 mg lucerastat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of 4000 mg lucerastat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Treatment D</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single oral dose of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lucerastat (Treatment A)</intervention_name>
    <description>2000 and 4000 mg; hard capsules for oral administration</description>
    <arm_group_label>Part A: Treatment 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>hard capsules for oral administration</description>
    <arm_group_label>Part A: Treatment 2</arm_group_label>
    <arm_group_label>Part B: Treatment D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <description>400 mg; film-coated tablets for oral administration</description>
    <arm_group_label>Part B: Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lucerastat (Treatment B)</intervention_name>
    <description>1000 mg; hard capsules for oral administration</description>
    <arm_group_label>Part B: Treatment B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lucerastat (Treatment C)</intervention_name>
    <description>4000 mg; hard capsules for oral administration</description>
    <arm_group_label>Part B: Treatment C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part A only:&#xD;
&#xD;
        - Healthy male subjects aged between 18 and 55 years.&#xD;
&#xD;
        Part B only:&#xD;
&#xD;
          -  Healthy male and female subjects aged between 18 and 55 years.&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test at Screening&#xD;
             and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must&#xD;
             consistently and correctly use a highly effective method of contraception, or be&#xD;
             sexually inactive, or have a vasectomized partner.&#xD;
&#xD;
          -  Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner&#xD;
             syndrome, uterine agenesis).&#xD;
&#xD;
        Part A and B:&#xD;
&#xD;
          -  Signed informed consent prior to any study-mandated procedure.&#xD;
&#xD;
          -  Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least&#xD;
             50.0 kg at Screening and prior to first study treatment administration.&#xD;
&#xD;
          -  Healthy on the basis of medical history, physical examination, cardiovascular&#xD;
             assessments and clinical laboratory tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Part B only:&#xD;
&#xD;
          -  Known hypersensitivity to moxifloxacin or any of its excipients.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Women planning to become pregnant.&#xD;
&#xD;
        Part A and B:&#xD;
&#xD;
          -  Previous exposure to lucerastat.&#xD;
&#xD;
          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect&#xD;
             full participation in the study or compliance with the protocol.&#xD;
&#xD;
          -  History or presence of rhythm disorders.&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Idorsia Pharmaceuticals Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QPS Netherlands B.V.</name>
      <address>
        <city>Groningen</city>
        <zip>9713</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</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>Moxifloxacin</mesh_term>
    <mesh_term>1-Deoxynojirimycin</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/NCT03832452
org study id: ID-069-106
secondary id: 2018-004546-42
nct id: NCT03832452
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses
      of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part
      B: TQT study)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
time frame: From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)
description: QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF
arm group label: Part A: Treatment 1
arm group type: Experimental
description: A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3
arm group label: Part A: Treatment 2
arm group type: Placebo Comparator
description: A single oral dose of placebo on Day 1 and 3
arm group label: Part B: Treatment A
arm group type: Active Comparator
description: A single oral dose of 400 mg moxifloxacin
arm group label: Part B: Treatment B
arm group type: Experimental
description: A single oral dose of 1000 mg lucerastat
arm group label: Part B: Treatment C
arm group type: Experimental
description: A single oral dose of 4000 mg lucerastat
arm group label: Part B: Treatment D
arm group type: Placebo Comparator
description: A single oral dose of placebo
intervention type: Drug
intervention name: Lucerastat (Treatment A)
description: 2000 and 4000 mg; hard capsules for oral administration
arm group label: Part A: Treatment 1
intervention type: Other
intervention name: Placebo
description: hard capsules for oral administration
arm group label: Part A: Treatment 2
arm group label: Part B: Treatment D
intervention type: Drug
intervention name: Moxifloxacin
description: 400 mg; film-coated tablets for oral administration
arm group label: Part B: Treatment A
intervention type: Drug
intervention name: Lucerastat (Treatment B)
description: 1000 mg; hard capsules for oral administration
arm group label: Part B: Treatment B
intervention type: Drug
intervention name: Lucerastat (Treatment C)
description: 4000 mg; hard capsules for oral administration
arm group label: Part B: Treatment C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Idorsia Pharmaceuticals Ltd.
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Moxifloxacin
mesh term: 1-Deoxynojirimycin
sharing ipd: No