Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

Korábbi kezelés

• Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues. scPharmaceuticals, Inc. SCP-111 PK/PD Study Protocol Number: scP-04-001 Confidential Page 14 of 56
• Administration of intravenous radiographic contrast agent within 72 hours prior to Screening.
• Concomitant or any use within past 30 days of drugs known to interact with furosemide (aminoglycoside antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, chloral hydrate, phenytoin, methotrexate, indomethacin, or lithium).
• Administration of an investigational drug or implantation of investigational device, or participation in another interventional clinical trial, within 30 days prior to Screening.
• Positive urine drug screen at Screening or Baseline.

Más betegség

• Heart rate > 110 beats per minute (BPM) at screening or baseline.
• Other significant cardiac abnormalities which may interfere with study participation or study assessments.
• Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker.
• Urinary retention due to bladder emptying disorders and/or urethral narrowing.
• Reported history of hepatic cirrhosis.
• 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.
• History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)

Laborértékek

• Serum potassium < 3.0 or > 5.5 mEq/L at screening.
• Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission < 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
• Blood alcohol concentration > 2 mg/dL (0.02%) at Screening.
• Alcohol breath test > 2 mg/dL (0.02%) on admission to the CRU.

Életkor

• Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.

Egyéb

• Systolic BP (SBP) < 90 mmHg at screening or baseline.
• Temperature > 38°C (oral or equivalent).
• Presence or need for urinary catheterization.

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female subjects 45 to 80 years of age.
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
• In the opinion of the Investigator, able to participate in the study.