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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2020-07-10
Summary
This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.
Conditions
- Healthy
Interventions
- DRUG
-
Furosemide 80 mg (8 mg/mL)
Furoscix will be administered as a subcutaneous infusion.
Sponsors & Collaborators
-
Clinical Trial Data Services, Inc.
collaborator UNKNOWN -
CSSi Life Sciences
collaborator INDUSTRY -
scPharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Samir Arora, MD · Aventiv Clinical Research
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-12-02
- Primary Completion
- 2020-06-24
- Completion
- 2020-06-26
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Food Effect Study of Febuxostat XR in Healthy Participants
NCT02374164 ·Status: COMPLETED ·Phase: PHASE1
-
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients
NCT03149939 ·Status: COMPLETED ·Phase: NA
-
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
NCT01563432 ·Status: COMPLETED ·Phase: PHASE1
-
Renal PK Study of LC350189
NCT04066712 ·Status: COMPLETED ·Phase: PHASE1
-
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
NCT01416402 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Hyperuricaemia on Chronic Renal Disease
NCT03425708 ·Status: UNKNOWN ·Phase: PHASE4
-
Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease
NCT01350388 ·Status: COMPLETED ·Phase: NA
-
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
NCT04157959 ·Status: UNKNOWN ·Phase: PHASE1
-
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
NCT04697602 ·Status: TERMINATED ·Phase: NA
-
The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients
NCT02338128 ·Status: COMPLETED
-
Safety and Efficacy Study of Intravenous Uricase-PEG 20
NCT01021241 ·Status: UNKNOWN ·Phase: PHASE1
-
Effect of Febuxostat on Blood Pressure
NCT01496469 ·Status: COMPLETED ·Phase: PHASE2
-
Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout
NCT02330796 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
NCT01736514 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
NCT00985127 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Safety of Febuxostat in Subjects With Gout.
NCT00174941 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
NCT01654276 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.
NCT04398251 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
NCT01361646 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
NCT07346027 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Role of Uralyt-U in Patients With Hyperuricemia
NCT04352153 ·Status: UNKNOWN ·Phase: NA
-
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
NCT01407874 ·Status: COMPLETED ·Phase: PHASE2
-
Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)
NCT01328769 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Study of an Acute Gout Regimen
NCT01017042 ·Status: COMPLETED ·Phase: PHASE1
-
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
NCT03512808 ·Status: COMPLETED ·Phase: PHASE1