Clinical trial NCT04846816: A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
Official title: An Open Label, Single Dose Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure: a Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: SQ Innovation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Glasgow
name: NHS Greater Glasgow and Clyde
First posted: 2021-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • Written informed consent

  * Male or female ≥18 years of age
  * Meet ESC criteria for diagnosis of HF(4)
  * Inpatient with a primary diagnosis of HF requiring treatment with intravenous furosemide at dose

Exclusion Criteria:

* • Unable to consent to inclusion in study due to lack of capacity

  * Requiring treatment with intravenous furosemide at dose \>200 mg per day as determined by the usual care team
  * Current inotropes, vasopressors or intra-aortic balloon pump therapy
  * Concomitant use of diuretics in 12 hours preceding administration of study drug with SQIN-Infusor
  * Systolic blood pressure (SBP) \<90 mmHg
  * Pregnancy or breastfeeding
  * Left sided valve disease with planned surgery or percutaneous intervention
  * Type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5)
  * Any surgical or medical condition which prevents patient from ambulation during the infusion
  * Renal impairment, defined as eGFR \< 30 mL/min/1.73 m2 at screening.
  * Patient on active cardiac transplant waiting list
  * Potassium \<3.0 mmol/L
  * Potassium \>6.0 mmol/L
  * Sodium \<125 mmol/L
  * Any contraindications for furosemide administration as per furosemide SmPC
  * Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data

Primary outcomes:
measure: To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).
timeFrame: 24 hours from start of infusion
measure: Infusion site pain
timeFrame: During 5 hour infusion
measure: Any device failures
timeFrame: During 5 hour infusion
measure: Serum furosemide concentration
timeFrame: At baseline
measure: Serum furosemide concentration
timeFrame: At 60 minutes
measure: Serum furosemide concentration
timeFrame: At 240 minutes
Secondary outcomes:
measure: Urine volume
timeFrame: 8 hours
measure: Sodium concentration in urine
timeFrame: 8 hours
measure: Presence of local skin reactions
timeFrame: After 5 hour infusion
measure: Patient acceptability
timeFrame: After 5 hour infusion
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Study officials:
affiliation: University of Glasgow
name: Mark Petrie, MBChB
role: STUDY_CHAIR
References: