Back to resultsSafety and Pharmacodynamic Study of CD-NP
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CD-NP
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Safety, Heart Failure
Eligibility 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
Sites / Locations
- DaVita Clinical Research
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482937
Brief Title
Safety and Pharmacodynamic Study of CD-NP
Official Title
A Phase I, Single Ascending Dose Trial to Examine the Safety and Pharmacodynamic Effects of CD-NP
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nile Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Safety, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CD-NP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
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Safety and Pharmacodynamic Study of CD-NP
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