<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/NCT02231190</url>
  </required_header>
  <id_info>
    <org_study_id>200884</org_study_id>
    <nct_id>NCT02231190</nct_id>
  </id_info>
  <brief_title>GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblinded) Study to Investigate Protective Effects of GSK1278863 on Eccentric Exercise Induced Muscle Damage in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from&#xD;
      unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study&#xD;
      is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after&#xD;
      unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or&#xD;
      placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863&#xD;
      on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1&#xD;
      subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral&#xD;
      doses of GSK1278863/placebo in total. The first dose will be administered immediately after&#xD;
      completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be&#xD;
      housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.&#xD;
      After enrolment of approximately 30 subjects, enrolment will be paused and planned interim&#xD;
      analysis will be performed to decide whether to terminate enrolment/study, continue dosing or&#xD;
      to reduce the dose to 5 milligrams (mg).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2015</start_date>
  <completion_date type="Actual">June 12, 2015</completion_date>
  <primary_completion_date type="Actual">June 12, 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>Maximal voluntary contraction (MVC) following eccentric exercise in subjects treated with GSK1278863 or placebo</measure>
    <time_frame>Up to 72 hours (hrs)</time_frame>
    <description>Muscle strength is a measure of the amount of force produced during a maximal voluntary contraction of the elbow flexors. It will be assessed in the non-dominant arm by a maximal isometric (fixed length) contraction using Cybex ergometer in a seated position after completion of eccentric exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in MVC following eccentric exercise from pre-eccentric exercise in subjects treated with GSK1278863 or placebo</measure>
    <time_frame>Up to 72 hrs</time_frame>
    <description>Change in muscle strength from pre-eccentric exercise to completion of eccentric exercise will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change in MVC following eccentric exercise from pre-eccentric exercise in subjects treated with GSK1278863 or placebo</measure>
    <time_frame>Up to 72 hrs</time_frame>
    <description>Percent change in muscle strength from pre-eccentric exercise to completion of eccentric exercise will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events(AE)</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs assessment as a safety measure</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Vital signs includes systolic and diastolic blood pressure, pulse rate and respiratory rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram (ECG) assessment as a safety measure</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, Total cardiac output (QT), and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory parameters assessment as a safety measure</measure>
    <time_frame>Up to Day 15</time_frame>
    <description>Laboratory parameters include hematology, clinical chemistry, and urinalysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject pain assessment using a visual analog scale</measure>
    <time_frame>Up to 72 hrs</time_frame>
    <description>Arm pain will be assessed for the exercised arm with a visual analog scale on a scale of 0-100 millimeter (mm) during two stimuli; during passive stretching and during MVC contraction, post-exercise and after completion of eccentric exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in degree of motion and resting arm angle from post-exercise</measure>
    <time_frame>Up to 72 hrs</time_frame>
    <description>Subjects will be asked to maximally flex their elbow and then maximally extend their elbow, joint angle will be measured using a manual goniometer at maximum flexion and maximum extension. Range of motion will be calculated by subtracting the flexion angle from the extension angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of PK parameters</measure>
    <time_frame>Up to Day 2</time_frame>
    <description>PK parameters include maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), and Area under the concentration-time curve from zero (pre-dose) to 24h [AUC(0-24)]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Tendon Injuries</condition>
  <arm_group>
    <arm_group_label>GSK1278863</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be given five oral doses of GSK1278863 100 mg (5mg if a low dose is elected for subjects enrolled after interim analysis). The first dose will be administered immediately after completion of eccentric exercise, and then at 4, 8, 24, and 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be given five oral doses of Placebo. The first dose will be administered immediately after completion of eccentric exercise, and then at 4, 8, 24, and 48 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK1278863</intervention_name>
    <description>GSK1278863 will be supplied as oral tablet of strength 100mg, 5mg(5mg if a low dose is elected for subjects enrolled after interim analysis) to be administered with 240 mL of water after end of eccentric exercise</description>
    <arm_group_label>GSK1278863</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>GSK1278863 matching placebo will be supplied as oral tablets for administration with 240 mL of water after end of eccentric exercise</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A subject will be eligible for inclusion in this study only if all of the following&#xD;
             criteria apply:&#xD;
&#xD;
          -  Males between 18 and 35 years of age inclusive, at the time of signing the informed&#xD;
             consent.&#xD;
&#xD;
          -  Healthy as determined by a responsible and experienced physician, based on a medical&#xD;
             evaluation including medical history, physical examination, laboratory tests and&#xD;
             cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s)&#xD;
             which is/are not specifically listed in the inclusion or exclusion criteria, outside&#xD;
             the reference range for the population being studied may be included only if the&#xD;
             Investigator in consultation with the GSK Medical Monitor agree and document that the&#xD;
             finding is unlikely to introduce additional risk factors and will not interfere with&#xD;
             the study procedures. Subjects with hemoglobin values outside the normal range should&#xD;
             always be excluded from enrolment.&#xD;
&#xD;
          -  Body weight &gt;= 70 kilogram (kg) and Body mass index (BMI) within the range 22.0 to&#xD;
             34.0 (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;
          -  Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin &lt;= 1.5x Upper limit&#xD;
             of normal (ULN) (isolated bilirubin &gt;1.5xULN is acceptable if bilirubin is&#xD;
             fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
          -  Corrected QT interval (QTc) &lt; 450 milliseconds (msec) based on single or average QTc&#xD;
             value of triplicate values obtained over a brief recording period. The QT correction&#xD;
             formula (Fridericia's) used to determine inclusion and discontinuation should be the&#xD;
             same throughout the study.&#xD;
&#xD;
          -  At least a 1year history of no regular (2-3 times per week) exercise and no heavy&#xD;
             exertion within past week, and in the examining physician's opinion the study&#xD;
             participant's physical condition/physique is consistent with a history of no regular&#xD;
             physical activity for the past year.&#xD;
&#xD;
          -  No strenuous exercise involving the arms during the last 10 weeks (e.g., resistance&#xD;
             training, rock climbing, rowing, chopping wood, digging, shovelling, sawing).&#xD;
&#xD;
          -  The subject is mentally and legally able to comply with the requirements and&#xD;
             restrictions of the protocol and has provided signed informed consent prior to&#xD;
             participation in any protocol-specific procedures, including Screening procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject will not be eligible for inclusion in this study if any of the following&#xD;
             criteria apply:&#xD;
&#xD;
        Criteria Based Upon Medical History&#xD;
&#xD;
          -  History of dizziness or vertigo.&#xD;
&#xD;
          -  Uncontrolled hypertension [diastolic blood pressure (BP) &gt;100 millimeter of mercury&#xD;
             (mmHg) or systolic BP &gt;170mmHg] at Screening.&#xD;
&#xD;
          -  Taking anti-inflammatory, glucocorticoid or other pain medication more than 2 times&#xD;
             per week over the previous month.&#xD;
&#xD;
          -  Unwilling to abstain from taking prescription or non-prescription drugs (including&#xD;
             vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is&#xD;
             a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first&#xD;
             dose of study medication until completion of the follow-up visit, unless in the&#xD;
             opinion of the Investigator and sponsor the medication will not interfere with the&#xD;
             study.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as:&#xD;
&#xD;
        An average weekly intake of &gt;14 drinks for males. One drink is equivalent to 12 grams(g) of&#xD;
        alcohol: 12 ounces [360 milliliter (mL)] of beer, 5 ounces (150mL) of wine or 1.5 ounces&#xD;
        (45mL) of 80 proof distilled spirits.&#xD;
&#xD;
          -  History of drug abuse or dependence within 6 months of the study.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the Investigator or GSK&#xD;
             Medical Monitor, contraindicates their participation.&#xD;
&#xD;
          -  History of peptic ulcer disease or upper gastrointestinal (GI) bleeding within the&#xD;
             past 6 months.&#xD;
&#xD;
          -  History of thrombosis defined as deep vein thrombosis, stroke, pulmonary embolism or&#xD;
             other thrombosis related condition within 3 months prior to Screening.&#xD;
&#xD;
          -  History of myocardial infarction or acute coronary syndrome within 3 months prior to&#xD;
             Screening.&#xD;
&#xD;
          -  History of stroke or transient ischemic attack within 3 months prior to Screening.&#xD;
&#xD;
          -  Subjects with a pre-existing condition interfering with normal gastrointestinal&#xD;
             anatomy or motility, and/or hepatic function that could interfere with the absorption,&#xD;
             metabolism, and/or excretion of GSK1278863. Examples of conditions that could&#xD;
             interfere with normal gastrointestinal anatomy or motility include gastrointestinal&#xD;
             bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy,&#xD;
             malabsorption, Crohn's disease, ulcerative colitis, or celiac sprue. Examples of&#xD;
             conditions that could interfere with hepatic function include Gilbert's syndrome.&#xD;
&#xD;
          -  Evidence of active peptic, duodenal or esophageal ulcer disease at Screening OR&#xD;
             history of clinically significant GI bleeding within 3 months prior to Screening.&#xD;
&#xD;
          -  Subjects with chronic inflammatory disease that could impact erythropoiesis (e.g.,&#xD;
             scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease).&#xD;
&#xD;
          -  Subjects with a history of symptomatic right heart failure.&#xD;
&#xD;
          -  Subjects with Class III or Class IV heart failure, as defined by the New York Heart&#xD;
             Association (NYHA) functional classification system.&#xD;
&#xD;
          -  History of proliferative vascular eye disease (e.g., choroidal or retinal disease,&#xD;
             such as neovascular age-related macular degeneration, proliferative diabetic&#xD;
             retinopathy or macular edema) based upon having had an ophthalmologic exam within 12&#xD;
             months prior to Screening.&#xD;
&#xD;
          -  History of risk factors for hypercoagulable state:&#xD;
&#xD;
          -  Factor V Leiden (the most common)&#xD;
&#xD;
          -  Prothrombin gene mutation&#xD;
&#xD;
          -  Deficiencies of natural proteins that prevent clotting (such as antithrombin III,&#xD;
             protein C and protein S)&#xD;
&#xD;
          -  Recent vascular trauma or surgeryd&#xD;
&#xD;
          -  Central venous catheter placement&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Antiphospholipid antibody syndrome&#xD;
&#xD;
          -  Myeloproliferative disorders such as polycythemia vera or essential thrombocytosis&#xD;
&#xD;
          -  Paroxysmal nocturnal hemoglobinuria&#xD;
&#xD;
          -  Nephrotic syndrome&#xD;
&#xD;
          -  Active malignancy or diagnosis of malignancy within 5 years prior to Screening&#xD;
             (excluding successfully treated basal or squamous cell carcinoma).&#xD;
&#xD;
        Criteria Based Upon Diagnostic Assessments&#xD;
&#xD;
          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody&#xD;
             result within 3 months of screening.&#xD;
&#xD;
          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or&#xD;
             nicotine-containing products within 6 months prior to screening.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen. A minimum list of drugs that will be&#xD;
             screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and&#xD;
             benzodiazepines.&#xD;
&#xD;
          -  A positive test for HIV antibody.&#xD;
&#xD;
          -  Screening hemoglobin level &gt; 17.0 grams per deciliter (g/dl).&#xD;
&#xD;
          -  Screening Creatine phosphokinase (CPK) &gt; 5xULN.&#xD;
&#xD;
          -  Screening serum creatinine &gt;1.10. Other Criteria&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500mL within a 56-day period.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures, or lifestyle and/or dietary&#xD;
             restrictions outlined in the informed consent and as directed by site staff.&#xD;
&#xD;
          -  Subject is either an immediate family member of a participating Investigator, study&#xD;
             coordinator, employee of an Investigator; or is a member of the staff conducting the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 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>Baltimore</city>
        <state>Maryland</state>
        <zip>21225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>muscle soreness</keyword>
  <keyword>Muscle damage and recovery</keyword>
  <keyword>muscle function</keyword>
  <keyword>eccentric exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendon Injuries</mesh_term>
  </condition_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/NCT02231190
org study id: 200884
nct id: NCT02231190
lead sponsor: 
has dmc: No
As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from
      unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study
      is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after
      unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or
      placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863
      on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1
      subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral
      doses of GSK1278863/placebo in total. The first dose will be administered immediately after
      completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be
      housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge.
      After enrolment of approximately 30 subjects, enrolment will be paused and planned interim
      analysis will be performed to decide whether to terminate enrolment/study, continue dosing or
      to reduce the dose to 5 milligrams (mg).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximal voluntary contraction (MVC) following eccentric exercise in subjects treated with GSK1278863 or placebo
time frame: Up to 72 hours (hrs)
description: Muscle strength is a measure of the amount of force produced during a maximal voluntary contraction of the elbow flexors. It will be assessed in the non-dominant arm by a maximal isometric (fixed length) contraction using Cybex ergometer in a seated position after completion of eccentric exercise
measure: Change in MVC following eccentric exercise from pre-eccentric exercise in subjects treated with GSK1278863 or placebo
time frame: Up to 72 hrs
description: Change in muscle strength from pre-eccentric exercise to completion of eccentric exercise will be assessed
measure: Percent change in MVC following eccentric exercise from pre-eccentric exercise in subjects treated with GSK1278863 or placebo
time frame: Up to 72 hrs
description: Percent change in muscle strength from pre-eccentric exercise to completion of eccentric exercise will be assessed
measure: Number of subjects with adverse events(AE)
time frame: Up to Day 15
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
measure: Vital signs assessment as a safety measure
time frame: Up to Day 15
description: Vital signs includes systolic and diastolic blood pressure, pulse rate and respiratory rate
measure: Electrocardiogram (ECG) assessment as a safety measure
time frame: Up to Day 15
description: Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, Total cardiac output (QT), and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals
measure: Laboratory parameters assessment as a safety measure
time frame: Up to Day 15
description: Laboratory parameters include hematology, clinical chemistry, and urinalysis
measure: Change in subject pain assessment using a visual analog scale
time frame: Up to 72 hrs
description: Arm pain will be assessed for the exercised arm with a visual analog scale on a scale of 0-100 millimeter (mm) during two stimuli; during passive stretching and during MVC contraction, post-exercise and after completion of eccentric exercise
measure: Change in degree of motion and resting arm angle from post-exercise
time frame: Up to 72 hrs
description: Subjects will be asked to maximally flex their elbow and then maximally extend their elbow, joint angle will be measured using a manual goniometer at maximum flexion and maximum extension. Range of motion will be calculated by subtracting the flexion angle from the extension angle
measure: Composite of PK parameters
time frame: Up to Day 2
description: PK parameters include maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), and Area under the concentration-time curve from zero (pre-dose) to 24h [AUC(0-24)]
arm group label: GSK1278863
arm group type: Experimental
description: Subjects will be given five oral doses of GSK1278863 100 mg (5mg if a low dose is elected for subjects enrolled after interim analysis). The first dose will be administered immediately after completion of eccentric exercise, and then at 4, 8, 24, and 48 hours
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will be given five oral doses of Placebo. The first dose will be administered immediately after completion of eccentric exercise, and then at 4, 8, 24, and 48 hours
intervention type: Drug
intervention name: GSK1278863
description: GSK1278863 will be supplied as oral tablet of strength 100mg, 5mg(5mg if a low dose is elected for subjects enrolled after interim analysis) to be administered with 240 mL of water after end of eccentric exercise
arm group label: GSK1278863
intervention type: Drug
intervention name: Placebo
description: GSK1278863 matching placebo will be supplied as oral tablets for administration with 240 mL of water after end of eccentric exercise
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendon Injuries