NCT00482937

Safety and Pharmacodynamic Study of CD-NP

A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Nile Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	CD-NP

Timeline

• Start date: 2007-01-01
• Completion: 2007-05-01
• First posted: 2007-06-06
• Last updated: 2007-06-06

Locations

1 site across 1 country: United States