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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Cenderitide is a dual receptor natriuretic peptide.
Orange County Research Center
Tustin, California, United States
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).
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