Ignite Creation Date:
2024-05-05 @ 9:23 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00879645
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2009-04-09
Brief Title:
Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Phase I Study to Assess the Pharmacokinetics of IK-1001 Sodium Sulfide in Subjects With Impaired Renal Function Following a Continuous 3-hour Intravenous Infusion
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to develop a rapid reliable assay to detect sulfide concentrations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 study to assess the pharmacokinetics PK of IK-1001 sodium sulfide in healthy volunteers as well as in subjects with varying degrees of impaired renal function A total of 28 subjects will be enrolled into the study over a 6 month period There will be 4 cohorts The first cohort will consist of subjects with mild renal impairment the fourth cohort will be subjects with intermediate renal impairment and the third cohort will be subjects with severe renal impairment and the second cohort will consist of normal healthy subjects All subjects will receive the study drug for 3 hours as a single intravenous IV infusion and will be followed over a 7 day period
Detailed Description:
This is a Phase 1 pharmacokinetic study to assess the pharmacokinetics of IK-1001 in healthy volunteers as well as subjects with varying degrees of impaired renal function following a single intravenous infusion
A total of 28 subjects will be enrolled into the study including 6 normal subjects Creatinine Clearance CrCL 80 mLmin 9 subjects with mild impairment CrCL 50 to 80 mLmin 6 subjects with intermediate impairment 30 to 50 mLmin and 7 subjects with severe impairment CrCL 30 mLmin
Mild moderate and normal healthy subjects will receive IK-1001 as a single IV infusion for 3 hours at 15 mgkghr Blood plasma urine and exhaled air will be collected from each subject over 48 hours and at follow-up visit Day 7 to evaluate pharmacokinetics of Hydrogen Sulfide H2S exhaled air IK-1001 blood and thiosulfate in plasma and urine Severe subjects will receive IK-1001 as a single IV infusion for 3 hours at 10 mgkghr
For each dosing cohort the study will consist of a screening visit Days -28 to -1 a treatment visit Day 0 check-in to Day 3 and a follow-up exit visit day 7 - 2 days
Study subjects will be enrolled to one of 4 cohorts and all will receive investigational product at the given dose level The subjects will be considered to be enrolled in the study at randomization
IK-1001 will be administered by a healthcare professional intravenously over 3 hours using an infusion pump Dosage of IK-1001 will be administered on actual body weight basis according to cohort assignment and using the subjects body weight determined on Day -1 After the end of the initial 3-hour study period subjects will be observed for an additional 45 hour period before discharge from the unit
A total of 28 subjects will be enrolled into the study including 6 normal subjects Creatinine Clearance CrCL 80 mLmin 9 subjects with mild impairment CrCL 50 to 80 mLmin 6 subjects with intermediate impairment 30 to 50 mLmin and 7 subjects with severe impairment CrCL 30 mLmin
Mild moderate and normal healthy subjects will receive IK-1001 as a single IV infusion for 3 hours at 15 mgkghr Blood plasma urine and exhaled air will be collected from each subject over 48 hours and at follow-up visit Day 7 to evaluate pharmacokinetics of Hydrogen Sulfide H2S exhaled air IK-1001 blood and thiosulfate in plasma and urine Severe subjects will receive IK-1001 as a single IV infusion for 3 hours at 10 mgkghr
For each dosing cohort the study will consist of a screening visit Days -28 to -1 a treatment visit Day 0 check-in to Day 3 and a follow-up exit visit day 7 - 2 days
Study subjects will be enrolled to one of 4 cohorts and all will receive investigational product at the given dose level The subjects will be considered to be enrolled in the study at randomization
IK-1001 will be administered by a healthcare professional intravenously over 3 hours using an infusion pump Dosage of IK-1001 will be administered on actual body weight basis according to cohort assignment and using the subjects body weight determined on Day -1 After the end of the initial 3-hour study period subjects will be observed for an additional 45 hour period before discharge from the unit
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