Furosemide Pharmacodynamics and Pharmacokinetics After Subcutaneous or Oral Administration

NCT ID: NCT02350725

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this pilot study is to investigate the pharmacodynamic and pharmacokinetic parameters of a novel furosemide formulation administered subcutaneously as compared to oral furosemide.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours followed by Oral Furosemide tablets (80 mg) in second period.

Group Type: EXPERIMENTAL

Furosemide injection solution for subcutaneous administration (80 mg)

Intervention Type: DRUG

Oral Furosemide tablets (80 mg)

Intervention Type: DRUG

Group 2

Oral Furosemide tablets (80 mg) followed by Furosemide injection solution for subcutaneous administration (80 mg) over 5 hours in second period.

Group Type: EXPERIMENTAL

Furosemide injection solution for subcutaneous administration (80 mg)

Intervention Type: DRUG

Oral Furosemide tablets (80 mg)

Intervention Type: DRUG

Interventions

Furosemide injection solution for subcutaneous administration (80 mg)

Intervention Type: DRUG

Oral Furosemide tablets (80 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained before any assessment is performed
• Male and female subjects ≥18 years of age, with body weight <120 kg and body mass index (BMI) <30 kg/m2
• Female subjects must be at least 2 years post-menopausal
• Participant must have been on oral furosemide (40 mg oid or bid) or therapeutic equivalent (bumetanide 1 mg oid or bid) for a period 90 days before the first dose of study medication
• History of chronic heart failure according to 2012 ESC guidelines with presence of moderate symptoms of chronic fluid overload. Chronic fluid overload is defined as presence of stable signs and symptoms of heart failure and congestion, like dyspnea at mild exertion or minimal exertion, pulmonary congestion and/or peripheral edema at the time of presentation in combination with elevated levels on natriuretic peptides (NT-proBNP > 300 ng/L)
• In the opinion of the investigator, able to participate in the study

Exclusion Criteria

• Acute Decompensated Heart Failure (ADHF) or recent history of ADHF or significant worsening in their HF symptoms (within prior 2 weeks)
• Contraindication to furosemide
• Systolic BP (SBP) < 90 mm Hg
• Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring i.v. anti-microbial treatment
• Serum sodium < 130 mmol/L and Serum potassium < 3.0 mmol/L
• Current or planned (throughout the completion of study drug infusion) treatment with any i.v. therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
• History of gastric or intestinal surgery that may affect absorption of oral medication
• Presence or need for urinary catheterization
• Current or planned ultrafiltration, hemofiltration, or dialysis
• Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission < 30 mL/min/1.73 m2 will be calculated as per standard at local laboratory
• Administration of intravenous radiographic contrast agent within 72 hours prior to screening or acute contrast-induced nephropathy at the time of screening
• Major surgery within 30 days prior to screening
• Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening
• Inability to follow instructions or comply with procedures
• Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

scPharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf A. de Boer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2014-002546-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SCP-01-001

Identifier Type: -

Identifier Source: org_study_id