Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482937
Status:
COMPLETED
Last Update Posted:
2007-06-06
First Post:
2007-06-04
Brief Title:
Safety and Pharmacodynamic Study of CD-NP
Sponsor:
Nile Therapeutics
Organization:
Nile Therapeutics
Study Overview
Official Title:
A Phase I Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP
Status:
COMPLETED
Status Verified Date:
2007-06
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 primary objective of this study is to establish the safety of CD-NP in normal human volunteers
Detailed Description:
The study will be conducted in two phases The first phase ascending dose phase will be an open-label study in cohorts of four 4 subjects entered two subjects at a time with the primary objective of establishing the safety of CD-NP The second phase MTD confirmation phase will be conducted under randomized double-blind placebo-controlled conditions in a larger cohort of subjects 10 subjects The primary objective of this phase will be to confirm the safety and pharmacodynamic findings at the apparent MTD
Secondary objectives include evaluation of the effect of CD-NP on mean arterial pressure MAP heart rate HR urinary sodium and potassium excretion UNaV and UKV respectively urinary flow rate UV and creatinine clearance Plasma concentrations of CD-NP angiotensin II and aldosterone and the urinary excretion rates of cGMP and CD-NP will also be determined
Secondary objectives include evaluation of the effect of CD-NP on mean arterial pressure MAP heart rate HR urinary sodium and potassium excretion UNaV and UKV respectively urinary flow rate UV and creatinine clearance Plasma concentrations of CD-NP angiotensin II and aldosterone and the urinary excretion rates of cGMP and CD-NP will also be determined
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