ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety and Pharmacodynamic Study of CD-NP

This study has been completed.

Sponsored by: Nile Therapeutics
Information provided by: Nile Therapeutics
ClinicalTrials.gov Identifier: NCT00482937
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Nile Therapeutics:

Enrollment:   22
Study Start Date:   January 2007
Study Completion Date:   May 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Be a healthy male using reliable contraception, a post-menopausal female, or a surgically sterilized female 18 to 60 years of age
  • Have a BMI within the range of 18–34 kg/m2
  • Be able to communicate effectively with the study personnel
  • Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic
  • Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities
  • Be nonsmokers defined as not having smoked in the past 6 months
  • Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication

Exclusion Criteria:

  • Known hypersensitivity or allergy to CD-NP or its components, nesiritide, other natriuretic peptides, or related compounds
  • Women who are pregnant or breast-feeding
  • Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
  • The presence of abnormal laboratory values which are considered clinically significant.
  • Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2).
  • Received an investigational drug within a period of 30 days prior to enrollment in the study.
  • Received any drug therapy within 1 week, or 5 half-lives, prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism. Use of NSAIDs, sulfonamides, probenecid or other drugs known to alter renal or tubular function is specifically prohibited for at least 5 half-lives prior to the first dose of any study related treatment.
  • Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
  • A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
  • A history (within the last 2 years) of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
  • A history of difficulty with donating blood. Donated blood or blood products within 45 days prior to enrollment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482937

Locations
United States, Minnesota
DaVita Clinical Research    
      Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators
Nile Therapeutics
  More Information


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

Keywords provided by Nile Therapeutics:
Safety  
Heart Failure  

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers