<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/NCT01673529</url>
  </required_header>
  <id_info>
    <org_study_id>115246</org_study_id>
    <nct_id>NCT01673529</nct_id>
  </id_info>
  <brief_title>Investigation of Topical SB705498 on Healthy Volunteers</brief_title>
  <official_title>A Two Part Randomized, Double-blind, Placebo Controlled Study to Investigate the Effects of Topical Doses of SB705498 Oncapsaicin, Histamine, and Cowhage Responses in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      A two part, randomized, double-blind, placebo controlled study to investigate the effects of&#xD;
      topical doses of SB705498 in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a two part, randomized, double-blind, placebo controlled study to investigate&#xD;
      the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in&#xD;
      healthy volunteers. Part A has been designed to establish whether the topical formulation is&#xD;
      capable of delivering SB705498 to the proposed site of action, and to select an appropriate&#xD;
      dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a&#xD;
      histaminergic and a non-histaminergic pathway, using two different challenge agents;&#xD;
      histamine and cowhage. This may provide important information about the role of TRPV1 in&#xD;
      pruritus and the therapeutic potential of SB705498.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2012</start_date>
  <completion_date type="Actual">October 4, 2012</completion_date>
  <primary_completion_date type="Actual">October 4, 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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of the area of flare induced by capsaicin as assessed by Laser</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>2) Average itch over maximum of 15 minutes post application of challenge agent</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>vital sign measurements, ECG, Clinical Laboratory data and Adverse Events</measure>
    <time_frame>3 months</time_frame>
    <description>safety and tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak itch intensity on 0 to 100 COVAS (Computerised visual analogue scale)</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>study population</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB705498</intervention_name>
    <description>1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.</description>
    <arm_group_label>study population</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match SB705498 will be used in both Part A and Part B of the study.</description>
    <arm_group_label>study population</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Caucasian volunteers aged between 18 and 65 years of age inclusive, at time of&#xD;
             signing the informed consent. Healthy subjects are defined as individuals who are not&#xD;
             taking any regular medication and are free from clinically significant illness or&#xD;
             disease as determined by their medical history (including family history), physical&#xD;
             examination, 12-lead ECG, laboratory studies, and other tests specified in this&#xD;
             protocol.&#xD;
&#xD;
          -  Subject has the ability to read, comprehend, and record information required by&#xD;
             protocol, and is willing and able to provide signed and dated written informed consent&#xD;
             prior to study participation, including compliance with the requirements and&#xD;
             restrictions listed in the consent form.&#xD;
&#xD;
          -  Non smoker who has not smoked or used nicotine containing products for a minimum&#xD;
             period of 6 months prior to the screening visit.&#xD;
&#xD;
          -  Subject must score greater than 40 on a COVAS scale of 0-100 for itch induced by both&#xD;
             cowhage and histamine at screening and show a flare response with capsaicin measured&#xD;
             by LDI scan.&#xD;
&#xD;
          -  Is willing to avoid UV exposure. i.e. use of Sun beds and sunbathing for 7 days prior&#xD;
             to screening, throughout the study and and until a week after the last dose. Subjects&#xD;
             who require treatment with photosensitizing drugs (e.g, tetracycline, thiazides,&#xD;
             fluoroquinolones, phenothiazines, or sulfonamides) will withdrawn. Subjects must also&#xD;
             be willing to use sunscreen of SPF30 or above on the volar surface of the forearms for&#xD;
             a week after the last dose.&#xD;
&#xD;
          -  A female subject is eligible to participate if she is of: Non-childbearing potential&#xD;
             defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or&#xD;
             postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a&#xD;
             blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40&#xD;
             MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory].&#xD;
             Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt&#xD;
             will be required to use one of the contraception methods in the protocol if they wish&#xD;
             to continue their HRT during the study.&#xD;
&#xD;
        Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior&#xD;
        to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the&#xD;
        cessation of therapy and the blood draw; this interval depends on the type and dosage of&#xD;
        HRT. Following confirmation of their post-menopausal status, they can resume use of HRT&#xD;
        during the study without use of a contraceptive method.]; Child-bearing potential and&#xD;
        agrees to use one of the contraception methods listed in the protocol. Female subjects&#xD;
        willing to participate in the study must agree to use contraception from the screening&#xD;
        visit until 15 days post-last treatment administration.&#xD;
&#xD;
          -  Male subjects must agree to use one of the contraception methods listed in the&#xD;
             protocol. For male subjects willing to participate in the study this criterion must be&#xD;
             followed from the time of the screening visit until 15 days post-last treatment&#xD;
&#xD;
          -  BMI within the range 19.0 - 32.0 kg/m2 (inclusive).&#xD;
&#xD;
          -  AST and ALT less than 2xULN; alkaline phosphatase and bilirubin less than and equal to&#xD;
             1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is&#xD;
             fractionated and direct bilirubin.&#xD;
&#xD;
          -  QTcB or QTcF less than 450 msec. Note that if the initial QTc value is prolonged, the&#xD;
             ECG should be repeated two more times (with 5 minutes between ECG readings) and the&#xD;
             average of the three QTc values used to determine eligibility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffers from skin infection or inflammation of the forearm, or has other arm skin&#xD;
             irregularities that may in the opinion of the investigator interfere with study&#xD;
             assessments (e.g. nevi, tattoos).&#xD;
&#xD;
          -  The subject suffers from eczema, psoriasis or any other acute or chronic&#xD;
             dermatological problem if, in the opinion of the investigator this is likely to&#xD;
             interfere with study assessments&#xD;
&#xD;
          -  Any subject with localised sunburn in the area to be treated as part of the study.&#xD;
&#xD;
          -  History of regular alcohol/drug consumption within 6 months of the study. Regular&#xD;
             alcohol consumption defined as: an average weekly intake of greater than 21 units for&#xD;
             males and greater than 14 units for females. One unit is equivalent to 8 g of alcohol:&#xD;
             a half-pint (approximately 240 ml) of beer, one glass (125 ml) of wine or one (25 ml)&#xD;
             measure of spirits.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen at screening visit. A minimum list of drugs&#xD;
             that will be screened for include amphetamines, barbiturates, cocaine, opiates,&#xD;
             cannabinoids and benzodiazepines.&#xD;
&#xD;
          -  The subject has participated in a clinical trial resulting in exposure to more than&#xD;
             four new chemical entities within 12 months prior to the first dosing day or has&#xD;
             received an investigational product within the following time period prior to the&#xD;
             first dosing day in the current study: 90 days, 5 half-lives or twice the duration of&#xD;
             the biological effect of the investigational product (whichever is longer).&#xD;
&#xD;
          -  Unable to refrain from use of prescription or non-prescription drugs. Refer to the&#xD;
             protocol for details.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications SB705498, challenge agents or&#xD;
             components thereof or a history of drug or other allergy that, in the opinion of the&#xD;
             investigator or GSK Medical Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within a 56 day period following completion of the study.&#xD;
&#xD;
          -  Lactating females.&#xD;
&#xD;
          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody&#xD;
             result within 3 months of screening&#xD;
&#xD;
          -  A positive test for HIV antibody.&#xD;
&#xD;
          -  Excessive caffeine drinkers (approximately 5 or more cups a day) or the subject is&#xD;
             unable to commit to refraining from caffeine-containing products for 24hrs prior to&#xD;
             each assessment visit and whilst present in the unit.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 2GG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>June 7, 2017</last_update_submitted>
  <last_update_submitted_qc>June 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pruritus</keyword>
  <keyword>TRPV1</keyword>
  <keyword>Cowhage</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Capsaicin</keyword>
  <keyword>Itch</keyword>
  <keyword>Histamine</keyword>
  <keyword>healthy volunteers</keyword>
  <keyword>SB705498</keyword>
  <keyword>Clinical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115246</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT01673529
org study id: 115246
nct id: NCT01673529
lead sponsor: 
A two part, randomized, double-blind, placebo controlled study to investigate the effects of
      topical doses of SB705498 in healthy volunteers.
This study is a two part, randomized, double-blind, placebo controlled study to investigate
      the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in
      healthy volunteers. Part A has been designed to establish whether the topical formulation is
      capable of delivering SB705498 to the proposed site of action, and to select an appropriate
      dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a
      histaminergic and a non-histaminergic pathway, using two different challenge agents;
      histamine and cowhage. This may provide important information about the role of TRPV1 in
      pruritus and the therapeutic potential of SB705498.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Measurement of the area of flare induced by capsaicin as assessed by Laser
time frame: 1 hour
measure: 2) Average itch over maximum of 15 minutes post application of challenge agent
time frame: 15 minutes
measure: vital sign measurements, ECG, Clinical Laboratory data and Adverse Events
time frame: 3 months
description: safety and tolerability
measure: Peak itch intensity on 0 to 100 COVAS (Computerised visual analogue scale)
time frame: 15 minutes
arm group label: study population
arm group type: Experimental
description: All subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator
intervention type: Drug
intervention name: SB705498
description: 1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.
arm group label: study population
intervention type: Drug
intervention name: Placebo
description: Placebo to match SB705498 will be used in both Part A and Part B of the study.
arm group label: study population
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 