[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374901":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":37,"centralContacts":36,"locations":42,"responsibleParty":55,"collaborators":57,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":36,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":36,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":36,"overallStatus":82,"whyStopped":36,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"scPharmaceuticals, Inc.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort One","EXPERIMENTAL","A bi-phasic delivery over 5 hours",[13],"Drug: Furosemide 80 mg (8 mg\u002FmL)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2a","Continuous infusion over 2 hours",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 2b","Bi-phasic delivery over 2 hours",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 3","Continuous infusion over 1 hour.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 4","Continuous infusion over 30 minutes.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Furosemide 80 mg (8 mg\u002FmL)","Furoscix will be administered as a subcutaneous infusion.",[15,19,23,27,9],null,[38],{"name":39,"affiliation":40,"role":41},"Samir Arora, MD","Aventiv Clinical Research","PRINCIPAL_INVESTIGATOR",[43],{"facility":40,"status":36,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":36},"Columbus","Ohio","42313","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.99879,39.96118,{"lat":53,"lon":52},{"type":56,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[58,61],{"name":59,"class":60},"Clinical Trial Data Services, Inc.","UNKNOWN",{"name":62,"class":6},"CSSi Life Sciences","100374901","phase-1-an-open-label-study-to-evaluate-the-impact-of-duration-of-subcutaneous-infusion-of-a-novel-ph-neutral-formulation-of-furosemide-furoscix-on-safety-and-local-skin-tolerability-100374901",false,"NCT04161482","An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability","Inclusion Criteria:\n\nSubjects are eligible for inclusion only if all of the following criteria are met:\n\n1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.\n2. Male and female Subjects 45-80 years of age.\n3. Have the ability to understand the requirements of the study and is willing to comply with all study procedures.\n4. In the opinion of the investigator, able to participate in the study.\n\nExclusion Criteria:\n\nA Subject is not eligible for inclusion if any of the following criteria apply:\n\n1. Receipt of loop diuretics (furosemide, bumetanide or torsemide) or thiazide diuretics (hydrochlorothiazide or metolazone) within 24 hours of study drug.\n2. Receipt of potassium-sparing diuretics (spironolactone, amiloride) or oral calcium, potassium or magnesium supplements (including multi-vitamins) within 24 hours of study drug.\n3. History of allergy to furosemide, sulfonamides or other loop diuretics.\n4. Any skin conditions currently requiring medical therapy.\n5. History of diabetes.\n6. Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination.\n7. Serum sodium \\\u003C130 mEq\u002FL at screening.\n8. Serum potassium \\\u003C 3.5 or \\> 5.5 mEq\u002FL at screening.\n9. Serum magnesium \\\u003C 1.5 or \\> 2.5 mEq\u002FL at screening.\n10. Serum chloride \\\u003C 96 or \\> 106 mEq\u002FL at screening.\n11. Serum calcium \\\u003C 8.5 or \\> 10.5 mg\u002FdL at screening.\n12. Estimated Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 by simplified Modification of Diet in Renal Disease (sMDRD) equation at screening.\n13. Systolic BP (SBP) \\\u003C 90 mm Hg at screening or baseline.\n14. Heart rate \\> 110 beats per minute (BPM) at screening or baseline.\n15. History of tinnitus or hearing impairment, including deafness.\n16. Temperature \\> 38°C (oral or equivalent) at screening or baseline.\n17. Blood alcohol concentration \\> 2 mg\u002FdL (0.02%) at screening or baseline.\n18. Female Subject who is pregnant or lactating.\n19. History of major abdominal surgery affecting the needle placement site.\n20. History of benign prostatic hyperplasia (BPH), prostatitis or prostate cancer.\n21. Urinary retention due to bladder emptying disorders and\u002For urethral narrowing.\n22. History of liver disease, cirrhosis, or ascites.\n23. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.\n24. Allergies and\u002For sensitivities to adhesive bandages or medical tape.\n25. Any surgical or medical condition which in the opinion of the Investigator may interfere with participation in the study or which may affect the outcome of the study.",true,"ALL","45 Years","80 Years",{"count":74,"type":75},39,"ACTUAL","INTERVENTIONAL",[78],"PHASE1","This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.",[81],"Healthy","COMPLETED","2020-07-09",{"date":85,"type":75},"2020-07-10",{"date":87,"type":75},"2019-12-02",{"date":89,"type":75},"2020-06-26",{"name":5,"class":6},1]