Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00961779
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2009-08-17
Brief Title:
Safety Study of NNZ-2566 in Healthy Female Subjects
Sponsor:
Neuren Pharmaceuticals Limited
Organization:
Neuren Pharmaceuticals Limited
Study Overview
Official Title:
A Phase I Double-Blind Randomized Dose Escalation Study to Assess the Safety Tolerability and PK of NNZ-2566 in Healthy Females When Administered as a Loading Dose 10-Min and as a Loading Dose Followed by a Maintenance Dose 72-Hr
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics PK of NNZ-2566 in healthy female volunteers
Detailed Description:
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers compared to placebo when administered as a 10 minute intravenous iv bolus infusion and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion
To determine the blood pharmacokinetics PK of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion
To determine the blood pharmacokinetics PK of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion
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