This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.
The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. This trial will investigate the on body performance of novel patch pump delivering the novel formulation. Study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7mL in patients with heart failure (HF). Recruitment will be restricted to 1 site with a recruitment target of 20 patients. All trial related activities will be conducted in an inpatient environment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).
Safety as determined by treatment emergent adverse events and adverse drug events
Time frame: 24 hours from start of infusion
Infusion site pain
Measured on a scale of 0 = no pain to 10 = most pain
Time frame: During 5 hour infusion
Any device failures
Any device failures
Time frame: During 5 hour infusion
Serum furosemide concentration
Serum furosemide concentration
Time frame: At baseline
Serum furosemide concentration
Serum furosemide concentration
Time frame: At 60 minutes
Serum furosemide concentration
Serum furosemide concentration
Time frame: At 240 minutes
Urine volume
Urine volume (ml) in urine collected 8 hours after start of SQIN-Furosemide infusion
Time frame: 8 hours
Sodium concentration in urine
Sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion
Time frame: 8 hours
Presence of local skin reactions
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Presence of local skin reactions on examination
Time frame: After 5 hour infusion
Patient acceptability
Patient acceptability using System Usability Scale - from 0 to 100 with a lower number correlating to poor usability and a higher number correlating to better usability by patients.
Time frame: After 5 hour infusion