<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/NCT01705938</url>
  </required_header>
  <id_info>
    <org_study_id>SP333101</org_study_id>
    <nct_id>NCT01705938</nct_id>
  </id_info>
  <brief_title>Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects</brief_title>
  <official_title>A First In Human, Single Blind, Placebo Controlled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SP-333 Tablets in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,&#xD;
      escalating, single-dose, study designed to evaluate the safety, tolerability,&#xD;
      pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333&#xD;
      tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, phase 1, single-blind, placebo controlled, single-dose, study designed&#xD;
      to evaluate the safety, tolerability, and pharmacokinetic properties of orally administered&#xD;
      SP-333 tablets. The study will include 7 groups of 8 subjects each (6 active, 2 placebo)&#xD;
      given a single oral dose of of SP-333 tablets or placebo. Following outpatient screening from&#xD;
      approximately 5 to 42 days before dosing, each subject will enter the Clinical Pharmacology&#xD;
      Unit (CPU) and will be housed from at least 48 hours, before dosing until 48 hours after&#xD;
      dosing. Subjects will be given single dose of the study drug on the day of dosing and remain&#xD;
      in the CPU for at least 48 hours. Subjects will return to the CPU on Days 8±1 and 15±1 for&#xD;
      safety follow up. Safety Committee Meetings will be conducted to review safety, tolerability,&#xD;
      and available Pharmacokinetic data from the current and previous treatment group(s), prior to&#xD;
      dosing subsequent treatment groups. Subjects in a given treatment group are considered&#xD;
      completers once they have completed the Day 15±1 day Follow up Visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with treatment emergent adverse events as a measure of safety and tolerability</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of SP-333 following single oral doses of tablets.</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Exposure</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 0.1 mg &amp; Placebo, one tablet by mouth, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 0.3 mg &amp; Placebo, 3 tablets by mouth, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 1 mg &amp; Placebo, one tablet by mouth, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 3 mg &amp; Placebo, 3 tablets by mouth,single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 10 mg &amp; Placebo, 1 tablet by mouth, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 30 mg &amp; Placebo, 3 tablets by mouth, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SP-333 60 mg &amp; Placebo, 6 tablets by mouth, single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SP-333</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_label>Group 7</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects between 18 and 55 years old&#xD;
&#xD;
          2. Body weight greater than or equal to 50 kg (110 pounds) and Body Mass Index (BMI) in&#xD;
             the range of 18 to 30 kg/ m2&#xD;
&#xD;
          3. Medically healthy with no clinically significant findings.&#xD;
&#xD;
          4. Subjects must have bowel habits that are considered regular (for this study a minimum&#xD;
             of 4 bowel movements a week without laxatives).&#xD;
&#xD;
          5. Subject must have had a bowel movement, without laxatives, in the 3 days before&#xD;
             administration of study drug.&#xD;
&#xD;
          6. Male subjects with female sexual partners of child-bearing potential must agree to use&#xD;
             highly effective contraceptive methods during the study.&#xD;
&#xD;
          7. Female subjects must be post-menopausal and not pregnant.&#xD;
&#xD;
          8. Subjects must understand and agree to comply with the requirements of the study and&#xD;
             they must be willing to sign an Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smokers or users of nicotine products who do not agree to not smoke or use nicotine&#xD;
             products during their stay in the CPU.&#xD;
&#xD;
          2. Current or history of clinically significant diseases, including gastrointestinal,&#xD;
             renal, hepatic, neurologic (e.g., neuropathy), hematologic, endocrine (e.g.,&#xD;
             diabetes), oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease&#xD;
             or any other condition.&#xD;
&#xD;
          3. Presence of any abnormal clinically significant laboratory.&#xD;
&#xD;
          4. History of any serious allergic reaction to any medication&#xD;
&#xD;
          5. Certain abnormalities of the ECG.&#xD;
&#xD;
          6. Participated in a previous clinical study with an investigational product within 30&#xD;
             days of study Participation&#xD;
&#xD;
          7. Donated blood, blood components or significant loss of blood within 2 months of dosing&#xD;
&#xD;
          8. History of a clinically-significant illness within 4 weeks of dosing&#xD;
&#xD;
          9. Special diet, any dietary habits, or restrictions, which, may interfere with conduct&#xD;
             of the study or health of the subject within 30 days of dosing&#xD;
&#xD;
         10. History of clinically-significant drug or alcohol abuse within 2 years of study&#xD;
             participation&#xD;
&#xD;
         11. Positive urine screen for prohibited drugs (cocaine, cannabinoids, opiates,&#xD;
             barbiturates, amphetamines, benzodiazepines, phencyclidine, propoxyphene).&#xD;
&#xD;
         12. History of human immunodeficiency virus (HIV), hepatitis B surface antigen positive&#xD;
             (+HBsAg), or hepatitis C antibody positive (+HCVAb).&#xD;
&#xD;
         13. History of certain surgeries:&#xD;
&#xD;
               -  Gastric bypass surgery or invasive procedure for the treatment of obesity or&#xD;
                  surgery to remove a segment of the gastrointestinal (GI) tract at any time.&#xD;
&#xD;
               -  Patients who have had a gastric band (unless the band has been completely removed&#xD;
                  for more than 60 days)&#xD;
&#xD;
               -  Surgery of the abdomen, pelvis or retroperitoneal structures within six months of&#xD;
                  study participation.&#xD;
&#xD;
               -  Appendectomy,Instrumentation of the bowel, major surgery within 60 days of study&#xD;
                  participation.&#xD;
&#xD;
         14. Female subjects of childbearing potential or who are breastfeeding&#xD;
&#xD;
         15. Use of any routine systemic medication, including any over the counter (OTC)&#xD;
             medication within 2 weeks of dosing&#xD;
&#xD;
         16. Use of herbal products, dietary supplements, vitamins, grapefruit, or grapefruit&#xD;
             containing products within 2 weeks of dosing&#xD;
&#xD;
         17. Irregular daily bowel habits&#xD;
&#xD;
         18. Any other issue which, in the judgment of the investigator, will make the subject&#xD;
             ineligible for study participation&#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>Peter Winkle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anaheim Clinical Trials</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 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>Dolcanatide</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/NCT01705938
org study id: SP333101
nct id: NCT01705938
lead sponsor: 
has dmc: No
This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,
      escalating, single-dose, study designed to evaluate the safety, tolerability,
      pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333
      tablets.
This is a randomized, phase 1, single-blind, placebo controlled, single-dose, study designed
      to evaluate the safety, tolerability, and pharmacokinetic properties of orally administered
      SP-333 tablets. The study will include 7 groups of 8 subjects each (6 active, 2 placebo)
      given a single oral dose of of SP-333 tablets or placebo. Following outpatient screening from
      approximately 5 to 42 days before dosing, each subject will enter the Clinical Pharmacology
      Unit (CPU) and will be housed from at least 48 hours, before dosing until 48 hours after
      dosing. Subjects will be given single dose of the study drug on the day of dosing and remain
      in the CPU for at least 48 hours. Subjects will return to the CPU on Days 8±1 and 15±1 for
      safety follow up. Safety Committee Meetings will be conducted to review safety, tolerability,
      and available Pharmacokinetic data from the current and previous treatment group(s), prior to
      dosing subsequent treatment groups. Subjects in a given treatment group are considered
      completers once they have completed the Day 15±1 day Follow up Visit.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
measure: Percentage of participants with treatment emergent adverse events as a measure of safety and tolerability
time frame: 14 days
measure: Area under the plasma concentration versus time curve (AUC) of SP-333 following single oral doses of tablets.
time frame: 48 hours
arm group label: Group 1
arm group type: Active Comparator
description: SP-333 0.1 mg & Placebo, one tablet by mouth, single dose
arm group label: Group 2
arm group type: Active Comparator
description: SP-333 0.3 mg & Placebo, 3 tablets by mouth, single dose
arm group label: Group 3
arm group type: Active Comparator
description: SP-333 1 mg & Placebo, one tablet by mouth, single dose
arm group label: Group 4
arm group type: Active Comparator
description: SP-333 3 mg & Placebo, 3 tablets by mouth,single dose
arm group label: Group 5
arm group type: Active Comparator
description: SP-333 10 mg & Placebo, 1 tablet by mouth, single dose
arm group label: Group 6
arm group type: Active Comparator
description: SP-333 30 mg & Placebo, 3 tablets by mouth, single dose
arm group label: Group 7
arm group type: Active Comparator
description: SP-333 60 mg & Placebo, 6 tablets by mouth, single dose
intervention type: Drug
intervention name: SP-333
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
arm group label: Group 6
arm group label: Group 7
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Winkle, MD
role: Principal Investigator
affiliation: Anaheim Clinical Trials
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dolcanatide