A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic
study. The study will be conducted in approximately 8-10 centers in the United States and
Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will
participate. Patients will receive a single IV injection of I5NP or placebo following
cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal
of the cardiopulmonary bypass machine (CBM).
The duration of the study is approximately 44 days, inclusive of a 14 day screening period.
Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient
visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital
discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be
made at 6 and 12 months after date of surgery.