Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00858936
Status:
TERMINATED
Last Update Posted:
2016-10-19
First Post:
2009-03-09
Brief Title:
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Study of IK-1001 to Evaluate Safety Pharmacokinetics and Proof-of-concept Efficacy for Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass GraftCABGSurgery
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Terminated - Company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will investigate the safety and effectiveness of IK-1001 the liquid form of sodium sulfide when used in Coronary Artery Bypass Graft CABG patients to potentially reduce the damage done to the heart during surgery
This study has 2 parts Part 1 will first test 36 subjects at different doses amount of the study drug There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients In Part 1 five subjects from each group will receive study drug IK-1001 and one will receive a placebo This first part of this study is also a dose amount escalation This means that each group will be receiving a different dose of the study drug The first group will receive the lowest dose the second group will receive a slightly higher dose and the third group a slightly higher dose until all six groups has been tested You can not choose which group you will be in but prior to starting each new dose level the data information from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level
Part 2 will expand the study and will treat at least 158 and up to 632 more subjects at a dose level that has been deemed safe from information collected from Part 1 Subjects in Part 2 of the study will have a 1 in 2 50 chance of receiving the study drug or placebo Whether the subject gets study drug or the placebo will be randomly assigned like the toss of a coin
The study drug or placebo will be given as an intravenous infusion into the vein for six hours while the subject is having their CABG surgery
The subjects will be followed up for 6 months after their CABG surgery
This study has 2 parts Part 1 will first test 36 subjects at different doses amount of the study drug There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients In Part 1 five subjects from each group will receive study drug IK-1001 and one will receive a placebo This first part of this study is also a dose amount escalation This means that each group will be receiving a different dose of the study drug The first group will receive the lowest dose the second group will receive a slightly higher dose and the third group a slightly higher dose until all six groups has been tested You can not choose which group you will be in but prior to starting each new dose level the data information from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level
Part 2 will expand the study and will treat at least 158 and up to 632 more subjects at a dose level that has been deemed safe from information collected from Part 1 Subjects in Part 2 of the study will have a 1 in 2 50 chance of receiving the study drug or placebo Whether the subject gets study drug or the placebo will be randomly assigned like the toss of a coin
The study drug or placebo will be given as an intravenous infusion into the vein for six hours while the subject is having their CABG surgery
The subjects will be followed up for 6 months after their CABG surgery
Detailed Description:
This is a phase 2 randomized double-blind placebo-controlled multicenter dose escalation and dose-expansion study that will evaluate safety PK and POC-efficacy of IK-1001 in subjects undergoing on pump CABG surgery who are at an increased risk for IR mediated tissue damage
Study subjects will undergo planned CABG surgery with cardiopulmonary bypass The study will be conducted in two parts Part 1 of the study will involve the dose escalation to evaluate safety PK and preliminary efficacy of IK-1001 Up to 36 eligible subjects will be enrolled into the Part 1 portion and randomized to receive either placebo n 6 or IK-1001 n 30 at 6 dose escalating levels of 02 05 075 10 125 and 15 mgkghr infusion for 6 hours
The study drug administration will begin in the operating room after the induction of anesthesia and prior to the surgical incision
After safety efficacy and PK data have been evaluated in Part 1 the optimum dose will be determined and this dose will be expanded in Part 2 Initially up to 158 eligible subjects will be randomized to receive either IK-1001 or placebo at a 11 ratio Part 2 aims to further establish safety PK as well as POC efficacy
In the event that none of the 4 primary endpoints reach at least a 15 decline as compared with placebo the Sponsor may decide to amend the protocol to explore a higher dose After 6 subjects have been dosed at this higher dose level the data will be reviewed by the Sponsor or designee for safety and PK and the remaining subjects will then be enrolled If the safety and PK data are favorable the study will be completed at this higher dose level
Study subjects will undergo planned CABG surgery with cardiopulmonary bypass The study will be conducted in two parts Part 1 of the study will involve the dose escalation to evaluate safety PK and preliminary efficacy of IK-1001 Up to 36 eligible subjects will be enrolled into the Part 1 portion and randomized to receive either placebo n 6 or IK-1001 n 30 at 6 dose escalating levels of 02 05 075 10 125 and 15 mgkghr infusion for 6 hours
The study drug administration will begin in the operating room after the induction of anesthesia and prior to the surgical incision
After safety efficacy and PK data have been evaluated in Part 1 the optimum dose will be determined and this dose will be expanded in Part 2 Initially up to 158 eligible subjects will be randomized to receive either IK-1001 or placebo at a 11 ratio Part 2 aims to further establish safety PK as well as POC efficacy
In the event that none of the 4 primary endpoints reach at least a 15 decline as compared with placebo the Sponsor may decide to amend the protocol to explore a higher dose After 6 subjects have been dosed at this higher dose level the data will be reviewed by the Sponsor or designee for safety and PK and the remaining subjects will then be enrolled If the safety and PK data are favorable the study will be completed at this higher dose level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None