<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/NCT02993055</url>
  </required_header>
  <id_info>
    <org_study_id>LP101-CL-101</org_study_id>
    <nct_id>NCT02993055</nct_id>
  </id_info>
  <brief_title>A Study to Assess Ulimorelin in Healthy Subjects</brief_title>
  <official_title>A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ulimorelin (LP101)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lyric Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lyric Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      A Phase I dose escalation study involving healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring the Cmax after administration of Ulimorelin</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Ulimorelin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ulimorelin</intervention_name>
    <arm_group_label>Ulimorelin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Ethics committee approved written informed consent and privacy language per national&#xD;
             regulations must be obtained from the subject before any study-related procedures&#xD;
             (including withdrawal of prohibited medication, if applicable)&#xD;
&#xD;
          2. Subject is a healthy male or non-pregnant (as documented by a negative urine pregnancy&#xD;
             test at screening and admission to the clinical study unit on Day -1 of the SAD phase&#xD;
             and Day -3 of MAD phase), non-lactating healthy female who is aged between 18 and 55&#xD;
             years, inclusive, weighs between 50 kg to 90 kg, and has a body mass index in the&#xD;
             range of 18 to 35 kg/m2 or, if outside the range, considered not clinically&#xD;
             significant by the investigator&#xD;
&#xD;
          3. Subject is a non-smoker and has not used tobacco for a minimum of 6 months before&#xD;
             screening (a breath carbon monoxide reading of ≤10 ppm at screening)&#xD;
&#xD;
          4. Subject must be willing and able to communicate and participate in the whole study&#xD;
&#xD;
          5. Must agree to use an adequate method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has clinically significant abnormal biochemistry, haematology or urinalysis as&#xD;
             judged by the investigator at screening or admission as determined by the investigator&#xD;
&#xD;
          2. Subject has abnormal and clinically significant 12-lead ECG at screening or on&#xD;
             admission to the clinical study unit at each period&#xD;
&#xD;
          3. Subject has 12-lead ECG demonstrating QTcF &gt;450 msec in males and &gt;470 msec in females&#xD;
             at screening. If QTcF exceeds these limits, the ECG should be repeated 2 more times at&#xD;
             least 1 minute apart, and the average of the 3 QTcF values should be used to determine&#xD;
             the subject's eligibility&#xD;
&#xD;
          4. Subject has a known serious adverse reaction or serious hypersensitivity to any drug&#xD;
             or the formulation excipients&#xD;
&#xD;
          5. Subjects who are study site employees, or immediate family members of a study site or&#xD;
             sponsor employee&#xD;
&#xD;
          6. Subject has supine blood pressure or pulse rate outside of the ranges 90 to 140 mmHg&#xD;
             systolic blood pressure/40 to 90 mmHg diastolic blood pressure and 50 to 90 bpm,&#xD;
             respectively, at screening or admission or a heart rate below 46 bpm at pre-dose on&#xD;
             Day 1 of either the SAD or MAD phase&#xD;
&#xD;
          7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or&#xD;
             human immunodeficiency virus (HIV) results&#xD;
&#xD;
          8. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other&#xD;
             than 2 g per day paracetamol) or herbal remedies in the 7 days before IMP&#xD;
             administration&#xD;
&#xD;
          9. Subject has received a vaccine within 30 days before first dosing&#xD;
&#xD;
         10. Subject has a history of drug or alcohol abuse within the past 2 years before&#xD;
             screening or a positive result for alcohol at screening or admission&#xD;
&#xD;
         11. Regular alcohol consumption in males &gt;21 units per week and females &gt;14 units per week&#xD;
             (1 unit = 1⁄2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)&#xD;
&#xD;
         12. Positive drugs of abuse test result&#xD;
&#xD;
         13. Subject has a history of any clinically significant neurological, GI (especially prior&#xD;
             gastric or oesophageal surgery, gastroparesis, peptic ulceration, GI bleeding,&#xD;
             ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome), renal, hepatic,&#xD;
             pulmonary, metabolic, cardiovascular, psychiatric, endocrine (diabetes mellitus),&#xD;
             respiratory or haematological disorder or disease or any other medical condition that,&#xD;
             in the opinion of the investigator, would preclude participation in the study&#xD;
&#xD;
         14. Subject has participated in another investigational study within the past 3 months&#xD;
             before study drug administration, or subject has previously participated in a study&#xD;
             with ulimorelin&#xD;
&#xD;
         15. Presence or history of clinically significant allergy requiring treatment, as judged&#xD;
             by the investigator. Hayfever is allowed unless it is active&#xD;
&#xD;
         16. Subjects who do not have suitable veins for multiple venepunctures/cannulation as&#xD;
             assessed by the investigator at screening&#xD;
&#xD;
         17. Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv&#xD;
             in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,&#xD;
             as defined in the Ionising Radiation Regulations 1999, shall participate in the study&#xD;
&#xD;
         18. Donation or loss of greater than 400 mL of blood within the previous 3 months&#xD;
&#xD;
         19. History of upper GI surgery&#xD;
&#xD;
         20. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If&#xD;
             screening occurs &gt;7 days before the first study day, this criterion will be determined&#xD;
             on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a&#xD;
             stool frequency of greater than 3 times per day. Constipation will be defined as a&#xD;
             failure to open the bowels more frequently than every other day&#xD;
&#xD;
         21. Subject has any other condition that in the opinion of the investigator precludes&#xD;
             participation in the trial&#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>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02993055
org study id: LP101-CL-101
nct id: NCT02993055
lead sponsor: 
A Phase I dose escalation study involving healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Measuring the Cmax after administration of Ulimorelin
time frame: 7 days
arm group label: Ulimorelin
arm group type: Experimental
description: Active
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Ulimorelin
arm group label: Ulimorelin
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No