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Sponsored by: |
Nile Therapeutics |
Information provided by: | Nile Therapeutics |
ClinicalTrials.gov Identifier: | NCT00482937 |
The primary objective of this study is to establish the safety of CD-NP in normal human volunteers.
Condition | Intervention | Phase |
Heart Failure, Congestive |
Drug: CD-NP |
Phase I |
MedlinePlus related topics: | Heart Failure |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP |
Enrollment: | 22 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2007 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NIL-CDNP-CT001 |
First Received: | June 4, 2007 |
Last Updated: | June 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00482937 |
Health Authority: | United States: Food and Drug Administration |
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