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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Infusion site pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
SQIN-01
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.
干预措施: SQIN-01 (Combination Product)
结局指标
主要结局
Infusion site pain
时间窗: During 5 hour infusion
Measured on a scale of 0 = no pain to 10 = most pain
Any device failures
时间窗: During 5 hour infusion
Any device failures
Serum furosemide concentration
时间窗: At 240 minutes
Serum furosemide concentration
To investigate the safety, tolerability, efficacy and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01).
时间窗: 24 hours from start of infusion
Safety as determined by treatment emergent adverse events and adverse drug events
To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01)
时间窗: 0-24 hours after infusion start
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 \[SADEs\]).
Infusion Site Pain
时间窗: Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion
Measured on a scale of 0 = no pain to 10 = maximal pain
Any Device Failures
时间窗: During 5 hour infusion
Any device failures (eg, adhesive failure and drug delivery failure)
Plasma Furosemide Concentration
时间窗: At baseline
Plasma furosemide concentration (at 0 min, pre-treatment)
Plasma Furosemide Concentration
时间窗: At 60 minutes
Plasma furosemide concentration
Plasma Furosemide Concentration
时间窗: At 240 minutes
Plasma furosemide concentration
次要结局
- Patient acceptability(After 5 hour infusion)
- Presence of local skin reactions(After 5 hour infusion)
- Urine volume(8 hours)
- Sodium concentration in urine(8 hours)
- Urine Volume(8 hours)
- Sodium Concentration in Urine(8 hours)
- Presence of Local Skin Reactions(Baseline, 5 hours post infusion start, and 24 hours post infusion start)
- Patient Acceptability(5 hours post infusion start)