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

NCT04161482 | Completed Phase 1 FDA Drug

• 1 other identifier: scP-01-007
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Infusion Site Pain (11 Point Pain Scale)

  Assessment of pain will be conducted upon placement of the subcutaneous (SC) needle, upon activation of SC infusion and periodically during the infusion and post-infusion completion for up to 8 hours after the start of the infusion using a standardized 11 point pain scale. Score will range from 0 to 10, where zero is equivalent to no pain and 10 is equivalent to the worst possible pain.

  8 hours

Secondary Outcomes (1)

• Safety (Adverse Events)

  Hours 1-8 and at the 24-48 hour follow up visit.

Study Arms (5)

Cohort One

EXPERIMENTAL

A bi-phasic delivery over 5 hours

Drug: Furosemide 80 mg (8 mg/mL)

Cohort 2a

EXPERIMENTAL

Continuous infusion over 2 hours

Drug: Furosemide 80 mg (8 mg/mL)

Cohort 2b

EXPERIMENTAL

Bi-phasic delivery over 2 hours

Drug: Furosemide 80 mg (8 mg/mL)

Cohort 3

EXPERIMENTAL

Continuous infusion over 1 hour.

Drug: Furosemide 80 mg (8 mg/mL)

Cohort 4

EXPERIMENTAL

Continuous infusion over 30 minutes.

Drug: Furosemide 80 mg (8 mg/mL)

Interventions

Furosemide 80 mg (8 mg/mL) DRUG

Furoscix will be administered as a subcutaneous infusion.

Cohort 2a; Cohort 2b; Cohort 3; Cohort 4; Cohort One

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female Subjects 45-80 years of age.
• Have the ability to understand the requirements of the study and is willing to comply with all study procedures.
• In the opinion of the investigator, able to participate in the study.

You may not qualify if:

• Receipt of loop diuretics (furosemide, bumetanide or torsemide) or thiazide diuretics (hydrochlorothiazide or metolazone) within 24 hours of study drug.
• Receipt of potassium-sparing diuretics (spironolactone, amiloride) or oral calcium, potassium or magnesium supplements (including multi-vitamins) within 24 hours of study drug.
• History of allergy to furosemide, sulfonamides or other loop diuretics.
• Any skin conditions currently requiring medical therapy.
• History of diabetes.
• Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination.
• Serum sodium \<130 mEq/L at screening.
• Serum potassium \< 3.5 or \> 5.5 mEq/L at screening.
• Serum magnesium \< 1.5 or \> 2.5 mEq/L at screening.
• Serum chloride \< 96 or \> 106 mEq/L at screening.
• Serum calcium \< 8.5 or \> 10.5 mg/dL at screening.
• Estimated Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease (sMDRD) equation at screening.
• Systolic BP (SBP) \< 90 mm Hg at screening or baseline.
• Heart rate \> 110 beats per minute (BPM) at screening or baseline.
• History of tinnitus or hearing impairment, including deafness.

Sponsors & Collaborators

• scPharmaceuticals, Inc.: lead
• Clinical Trial Data Services, Inc.: collaborator
• CSSi Life Sciences: collaborator

Study Sites (1)

Aventiv Clinical Research

Columbus, Ohio, 42313, United States

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Samir Arora, MD

  Aventiv Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The initial cohort (Cohort 1) will receive 80 mg (10 mL) with a bi-phasic delivery profile over 5 hours. Cohort 2a will evaluate a 2-hour infusion and Cohort 2b will be a bi-phasic delivery over 2 hours. Cohorts 3 and 4 will deliver the Furoscix over one hour and 30 minutes, respectively.

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 13, 2019
• Study Start: December 2, 2019
• Primary Completion: June 24, 2020
• Study Completion: June 26, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (1)