Safety and Pharmacodynamic Study of CD-NP

NCT00482937 | Completed Phase 1

• 1 other identifier: NIL-CDNP-CT001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to establish the safety of CD-NP in normal human volunteers.

Conditions

Heart Failure, Congestive

Keywords

Safety; Heart Failure

Interventions

CD-NP DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Nile Therapeutics: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 6, 2007
• Study Start: January 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 6, 2007

Record last verified: 2007-06

Locations

US (1)