A phase II randomized, double-blind, placebo-controlled, multi-center study to evaluate tolerability, safety pharmacokinetics and efficacy of intravenous INO-1001 in high-risk subjects undergoing cardiopulmonary by-pass for coronary revascularization and/or valve surgery. - NA
- Conditions
- INO-1001 is being developed for the treatment of high-risk subjects undergoing cardiopulmonary bypass (CPB) for coronary revascularization and/or valve surgery.
- Registration Number
- EUCTR2005-000464-95-CZ
- Lead Sponsor
- Inotek Pharmaceuticals Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 162
All eligible subjects must meet all of the following criteria:
•Scheduled to undergo elective cardiopulmonary bypass for coronary revascularization and/or valve surgery
•Written informed consent must be obtained prior to participation
•Age eighteen (18) to ninety (90) years (inclusive)
•Males and non-pregnant non-lactating femals of child-bearing potential who agree to use two effective methods of contraception (e.g. condom and spermicide) for three (3) months following exposure to the study drug.
•Third (Main) Phase ONLY: European System for Cardiac Operative Risk Evaluation (euroSCORE) equal to or greater than six calculated at any time within ninety-six hours prior to anticipated study drug administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
To be eligible for entry into the study, subjects must not have any of the following criteria:
•History of a hypersensitivity reaction to more than three drugs or to mannitol
•Participation in any other investigational study within thirty (30) days of the Screening Phase
•Myocardial infarction within seventy-two (72) hours of the study drug infusion
•Clinically significant abnormalities in any clinical laboratory tests, as judged by a Clinical Investigator
•Clinically significant hematological, hepatic, renal, pulmonary, or gastrointestinal disorder, as judged by a Clinical Investigator
•Any known malignancy other than treated basal cell skin cancer or cervical carcinoma in situ
•Dialysis, creatinine > 2 mg/dl, or ALT or AST above the upper limits of normal
•History of Hepatitis B, Hepatitis C, acute or chronic hepatitis, or history / demonstration of HIV antibodies or AIDS
•Female subjects who are currently pregnant, lactating, or have a positive pregnancy test
•Any recent (acute) or chronic medical, psychological or social issue that in the opinion of the investigator might interfere with the performance, completion, or interpretation of this study
•Subjects who have received an irreversible CYP3A4 inhibitor orally or parenterally within approximately three (3) days of study drug administration, including azole antifungals (e.g. ketoconazole, itraconazole, miconazole, fluconazole); macrolide antibiotics (e.g. clarithromycin, erythromycin, troleandomycin; but not azithromycin); HIV-related protease inhibitors (e.g. Crixivan [Indinavir], Invirase [saquinavir], Norvir [ritonavir], and Viracept [nelfinavir]); the anti-depressant nefazodone; and the long-acting benzodiazepines (e.g. diazepam).
•Subjects who have received the potent irreversible CYP3A4 inhibitors verapamil or diltiazem within approximately seven (7) days of study drug administration.
•Subjects who have received amiodarone within thirty (30) days of the study drug administration
•Subjects with repeated demonstration of a QTc intervals > 450 msecs or known Long QT Syndrome
•Known alcohol or drug abuse within the last year
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method