<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/NCT01661244</url>
  </required_header>
  <id_info>
    <org_study_id>RVH007</org_study_id>
    <nct_id>NCT01661244</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety and Tolerability of a New Inhaled Formulation of RV568 in Healthy Volunteers</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV568 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Respivert Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Respivert Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RV568 is being developed as a possible treatment of smoking related lung disease (also known&#xD;
      as Chronic Obstructive Pulmonary Disease - COPD).&#xD;
&#xD;
      The main purpose of this study is to examine the safety and tolerability of a new inhaled&#xD;
      formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and&#xD;
      Part B. Part A (Cohorts 1, 2 &amp; 3) will investigate 6 different dose levels of RV568 given as&#xD;
      a single dose and Part B (Cohorts 4 &amp; 5) will investigate 2 different dose levels of RV568&#xD;
      given once a day for 14 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment emergent adverse events</measure>
    <time_frame>Cohort 1, 56 days; Cohorts 2 &amp; 3, 28 days; Cohorts 4 &amp; 5, 35 days</time_frame>
    <description>Assessment of the number of adverse events reported by subjects following dosing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG assessment</measure>
    <time_frame>Cohort 1, 56 days; Cohorts 2 &amp; 3, 28 days; Cohorts 4 &amp; 5, 35 days</time_frame>
    <description>Change from pre-dose values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital signs assessment</measure>
    <time_frame>Cohort 1, 56 days; Cohorts 2 &amp; 3, 28 days; Cohorts 4 &amp; 5, 35 days</time_frame>
    <description>Change from pre-dose values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spirometry assessment</measure>
    <time_frame>Cohort 1, 56 days; Cohorts 2 &amp; 3, 28 days; Cohorts 4 &amp; 5, 35 days</time_frame>
    <description>Change from pre-dose values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma RV568 levels</measure>
    <time_frame>Cohorts 1, 2 &amp; 3: Day 1 (0, 15, 30 &amp; 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), then 7, 14 and 28 days. Cohorts 4 &amp; 5: Day 1, 7 &amp; 14 (0, 15, 30 &amp; 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), Day 10, 11, 12 &amp; 13 (0 &amp; 30 min), then Day 21, 28 and 35</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>COPD</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part A - Single dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - 14 day repeat dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RV568 single dose</intervention_name>
    <description>Safety and tolerability of single escalating doses in normal human volunteers</description>
    <arm_group_label>Part A - Single dose escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RV568 matching placebo single dose</intervention_name>
    <description>Safety and tolerability of escalating repeat doses in normal human volunteers.</description>
    <arm_group_label>Part A - Single dose escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RV568 repeat dose</intervention_name>
    <description>Safety and tolerability of escalating repeat doses in normal human volunteers.</description>
    <arm_group_label>Part B - 14 day repeat dose escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RV568 matching placebo repeat dose</intervention_name>
    <description>Safety and tolerability of escalating repeat doses in normal human volunteers.</description>
    <arm_group_label>Part B - 14 day repeat dose escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 18 and 65 years of age inclusive, at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          -  Healthy as determined by a physician, based on a full medical evaluation including&#xD;
             medical history, physical examination, and laboratory tests.&#xD;
&#xD;
          -  Body weight ≥50 kg and body mass index within the range 19-29 kg/m2 (inclusive).&#xD;
&#xD;
          -  Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the consent form.&#xD;
&#xD;
          -  Average QTc(B) or QTc(F) &lt;450 msec (or QTc &lt;480 msec in healthy subjects with right&#xD;
             bundle branch block).&#xD;
&#xD;
          -  Capable of complying with all study restrictions and procedures including ability to&#xD;
             use the Dry Powder Inhaler correctly.&#xD;
&#xD;
          -  Spirometry readings (FEV1 and FVC) to be ≥ 80% predicted value and FEV1/FVC ratio &gt;&#xD;
             0.7 calculated using ECCS reference equations.&#xD;
&#xD;
          -  Vital sign assessments within normal ranges (systolic blood pressure (SBP) 90 140&#xD;
             mm/Hg; diastolic blood pressure (DBP) 55 - 90 mm/Hg; heart rate (HR) 40 - 100 bpm).&#xD;
&#xD;
          -  Agree not to use prescription medications within 14 days before first administration&#xD;
             of study medication and through the duration of the study (with the exception of&#xD;
             contraception and hormone replacement therapy (HRT)).&#xD;
&#xD;
          -  Agree not to use over the counter (OTC) medications (including corticosteroids,&#xD;
             decongestants, antihistamines, aspirin and other non-steroidal anti-inflammatory drugs&#xD;
             (NSAIDs)) and herbal medication (including, but not limited to, herbal tea and St.&#xD;
             John's Wort), within 14 days before first administration of study medication and&#xD;
             through to the final follow up visit, unless approved by the Investigator and Sponsor&#xD;
             Medical Monitor. Occasional use of paracetamol at recommended doses (≤ 1 g/ 6 hours&#xD;
             and ≤ 2 g/day) and continued pre-existing use of vitamins at recommended doses is&#xD;
             allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any acute or chronic illness or clinically relevant abnormality identified on the&#xD;
             screening medical assessment, laboratory tests or ECG.&#xD;
&#xD;
          -  Upper or lower respiratory tract infection within 4 weeks of the screening visit.&#xD;
&#xD;
          -  A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody&#xD;
             result at screening.&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  Positive urinary drugs or breath alcohol test at screening or prior to dosing.&#xD;
&#xD;
          -  The Investigator suspects drug or alcohol abuse.&#xD;
&#xD;
          -  A positive test for human immunodeficiency virus antibody.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study.&#xD;
&#xD;
          -  The subject has participated in any other study of an investigational drug during the&#xD;
             3 months before receipt of the first dose of study medication or has previously&#xD;
             received RV568.&#xD;
&#xD;
          -  Regular use of prescription or non-prescription drugs within 14 days prior to the&#xD;
             first dose of study medication.&#xD;
&#xD;
          -  Allergy to any of the active or inactive ingredients in the study medication.&#xD;
&#xD;
          -  History of drug, or other allergy that, in the opinion of the Investigator or Sponsor&#xD;
             Medical Monitor, would contraindicate their participation.&#xD;
&#xD;
          -  The subject is a smoker (regular or irregular), or has smoked or used&#xD;
             nicotine-containing products within the 6 months prior to screening.&#xD;
&#xD;
          -  Positive carbon monoxide breath test at the screening visit indicative of smoking or&#xD;
             use of tobacco or nicotine-containing products.&#xD;
&#xD;
          -  Donation of blood in excess of 500 mL within a 3 month period prior to screening, or&#xD;
             if study participation would result in blood loss in excess of 500 mL in a 3 month&#xD;
             period.&#xD;
&#xD;
          -  The subject is unable or unwilling to comply fully with the study protocol.&#xD;
&#xD;
          -  Subject is mentally or legally incapacitated.&#xD;
&#xD;
          -  Subject is an employee of the Sponsor or contract research organization (CRO), or a&#xD;
             relative of an employee of the Sponsor or CRO.&#xD;
&#xD;
          -  Unable or unwilling to undergo multiple venepuncture procedures or the subject has&#xD;
             poor access to veins suitable for cannulation.&#xD;
&#xD;
          -  A positive pregnancy test or is a lactating (nursing) female.&#xD;
&#xD;
          -  Any other reason that the Investigator considers makes the subject unsuitable to&#xD;
             participate.&#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>Dr Garth Rapeport</last_name>
    <role>Study Director</role>
    <affiliation>Respivert Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>NW10 7EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>March 1, 2013</last_update_submitted>
  <last_update_submitted_qc>March 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01661244
org study id: RVH007
nct id: NCT01661244
lead sponsor: 
has dmc: No
RV568 is being developed as a possible treatment of smoking related lung disease (also known
      as Chronic Obstructive Pulmonary Disease - COPD).

      The main purpose of this study is to examine the safety and tolerability of a new inhaled
      formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and
      Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as
      a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568
      given once a day for 14 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence of treatment emergent adverse events
time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
description: Assessment of the number of adverse events reported by subjects following dosing.
measure: ECG assessment
time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
description: Change from pre-dose values.
measure: Vital signs assessment
time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
description: Change from pre-dose values
measure: Spirometry assessment
time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
description: Change from pre-dose values
measure: Plasma RV568 levels
time frame: Cohorts 1, 2 & 3: Day 1 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), then 7, 14 and 28 days. Cohorts 4 & 5: Day 1, 7 & 14 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), Day 10, 11, 12 & 13 (0 & 30 min), then Day 21, 28 and 35
arm group label: Part A - Single dose escalation
arm group type: Experimental
arm group label: Part B - 14 day repeat dose escalation
arm group type: Experimental
intervention type: Drug
intervention name: RV568 single dose
description: Safety and tolerability of single escalating doses in normal human volunteers
arm group label: Part A - Single dose escalation
intervention type: Drug
intervention name: RV568 matching placebo single dose
description: Safety and tolerability of escalating repeat doses in normal human volunteers.
arm group label: Part A - Single dose escalation
intervention type: Drug
intervention name: RV568 repeat dose
description: Safety and tolerability of escalating repeat doses in normal human volunteers.
arm group label: Part B - 14 day repeat dose escalation
intervention type: Drug
intervention name: RV568 matching placebo repeat dose
description: Safety and tolerability of escalating repeat doses in normal human volunteers.
arm group label: Part B - 14 day repeat dose escalation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Garth Rapeport
role: Study Director
affiliation: Respivert Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor