Safety Study of Cenderitide in Stable Chronic Heart Failure
This trial is active, not recruiting.
|Start date||January 2015|
|End date||July 2015|
|Trial size||12 participants|
|Trial identifier||NCT02359227, CDNP-578-01|
Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.
|Intervention model||single group assignment|
Safety and tolerability as assessed by changes in vital signs (blood pressure, heart rate, and body temperature), clinical laboratory tests, adverse events, 12-lead ECGs, and physical examinations compared to pre-dose, baseline measurements.
time frame: Measurements performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).
Pharmacokinetic (PK) profile of cenderitide as measured in area under the blood concentration-curve (AUC) from time zero to 48 hours post each infusion rate start, maximum blood concentration (Cmax), and time of maximum blood concentration (Tmax).
time frame: PK blood collection at regular intervals on Days 1-10.
Pharmacodynamic (PD) response as assessed by changes in blood pressure, heart rate, weight, fluid balance (intake/output), plasma cGMP, ANP, NT-proBNP, and aldosterone, and urine cGMP compared to pre-dose baseline assessments.
time frame: PD assessments performed at regular intervals on Days 1-10, and at the safety follow-up visit (Day 16 ± 2 days).
Male or female participants at least 18 years old.
Key Inclusion Criteria: - Male or female, ≥ 18 years of age - Body Mass Index (BMI) of 18-40 kg/m2, inclusive - Current or historical New York Heart Association (NYHA) functional class ≥ II - At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL) - Systolic blood pressure 100-160 mmHg - Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening Key Exclusion Criteria: - Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds - Current clinical diagnosis of acute decompensated heart failure (ADHF) - Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening. - Symptomatic postural hypotension - Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events - Clinically significant aortic or mitral valve stenosis - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) - Severe renal failure defined as creatinine clearance < 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations - Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids) - Known hepatic impairment as indicated by any of the following: A) total bilirubin > 3 mg/dL; B) albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction
|Official title||A Study Assessing the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous, Stepwise, Dose Increasing, Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Subjects With Stable, Chronic Heart Failure|
|Principal investigator||Joel Neutel, MD|
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