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, 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)
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 (TEAEs), (including serious adverse events \[SAEs\]) and adverse drug events (ADEs) (including serious adverse drug events \[SADEs\]).
Time frame: 0-24 hours after infusion start
Infusion Site Pain
Measured on a scale of 0 = no pain to 10 = maximal pain
Time frame: Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion
Any Device Failures
Any device failures (eg, adhesive failure and drug delivery failure)
Time frame: During 5 hour infusion
Plasma Furosemide Concentration
Plasma furosemide concentration (at 0 min, pre-treatment)
Time frame: At baseline
Plasma Furosemide Concentration
Plasma furosemide concentration
Time frame: At 60 minutes
Plasma Furosemide Concentration
Plasma furosemide concentration
Time frame: At 240 minutes
Urine Volume
Cumulative urine volume (ml) in urine collected over 8 hours from the start of SQIN-Furosemide infusion
Time frame: 8 hours
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Sodium Concentration in Urine
Spot sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion
Time frame: 8 hours
Presence of Local Skin Reactions
Presence of local skin reactions on examination (Erythma/Edema Score: 0 = No skin response; ½ = Questionable or faint, indistinct erythema; 1 = Well-defined erythema; 2 = Erythema with slight to moderate edema; 3 = Vesicles (small blisters) or papules (small, circumscribed elevations); 4 = Bullous (large blister), spreading, or other severe reaction.)
Time frame: Baseline, 5 hours post infusion start, and 24 hours post infusion start
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: 5 hours post infusion start