Gender Healthy Contraceptive methods | Postmenopausal state | Female Sterilization | Age
Item
be a healthy male using reliable contraception, a post-menopausal female, or a surgically sterilized female 18 to 60 years of age
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Body mass index
Item
have a bmi within the range of 18–34 kg/m2
boolean
C1305855 (UMLS CUI [1])
Able to communicate Study Personnel
Item
be able to communicate effectively with the study personnel
boolean
C2364293 (UMLS CUI [1,1])
C2985653 (UMLS CUI [1,2])
Disease Absent | Laboratory test result abnormal Absent | Medical History | Physical Examination | Laboratory data interpretation
Item
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
boolean
C0012634 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0262707 (UMLS CUI [5])
12 lead ECG Normal
Item
have a normal 12-lead electrocardiogram, without any clinically significant abnormalities
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Non-smoker
Item
be nonsmokers defined as not having smoked in the past 6 months
boolean
C0337672 (UMLS CUI [1])
Informed Consent
Item
be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication
boolean
C0021430 (UMLS CUI [1])
Hypersensitivity CD-NP | Hypersensitivity CD-NP Component | Hypersensitivity Nesiritide | Hypersensitivity Natriuretic Peptides | Hypersensitivity Compound Related
Item
known hypersensitivity or allergy to cd-np or its components, nesiritide, other natriuretic peptides, or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C2717567 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2717567 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0054015 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1144709 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1706082 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition compromises Hematological system | Condition compromises Cardiovascular system | Condition compromises Pulmonary system | Condition compromises Renal system | Condition compromises Gastrointestinal system | Condition compromises Liver | Condition compromises Central Nervous System | Condition Interferes with Absorption Investigational New Drug | Condition Interferes with Distribution Investigational New Drug | Condition Interferes with Metabolism Investigational New Drug | Condition Interferes with Excretion Investigational New Drug | Condition Patient At risk Increased
Item
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
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0279810 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0007226 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0884309 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0449913 (UMLS CUI [4,3])
C0022646 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0012240 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0023884 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C3714787 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0348080 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C1378698 (UMLS CUI [9,3])
C0013230 (UMLS CUI [9,4])
C0348080 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0025520 (UMLS CUI [10,3])
C0013230 (UMLS CUI [10,4])
C0348080 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0683141 (UMLS CUI [11,3])
C0013230 (UMLS CUI [11,4])
C0348080 (UMLS CUI [12,1])
C0030705 (UMLS CUI [12,2])
C1444641 (UMLS CUI [12,3])
C0205217 (UMLS CUI [12,4])
Laboratory test result abnormal
Item
the presence of abnormal laboratory values which are considered clinically significant.
boolean
C0438215 (UMLS CUI [1])
Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive screen for hepatitis b (hbsag, hepatitis b surface antigen), hepatitis c (anti hcv, hepatitis c antibody), or hiv (anti-hiv 1/2).
boolean
C0856706 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Investigational New Drugs
Item
received an investigational drug within a period of 30 days prior to enrollment in the study.
boolean
C0013230 (UMLS CUI [1])
Pharmacotherapy | Pharmaceutical Preparations Causing Drug Metabolism Induction Hepatic | Pharmaceutical Preparations Causing Drug Metabolism Inhibition Hepatic | Anti-Inflammatory Agents, Non-Steroidal | Sulfonamides | Probenecid | Pharmaceutical Preparations Causing Renal alteration | Pharmaceutical Preparations Causing Renal tubular function Alteration
Item
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.
boolean
C0013216 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1512074 (UMLS CUI [2,3])
C0205054 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C1512075 (UMLS CUI [3,3])
C0205054 (UMLS CUI [3,4])
C0003211 (UMLS CUI [4])
C0038760 (UMLS CUI [5])
C0033209 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0184571 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0678227 (UMLS CUI [8,2])
C0678875 (UMLS CUI [8,3])
C1515926 (UMLS CUI [8,4])
Alcohol consumption
Item
consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
boolean
C0001948 (UMLS CUI [1])
Urine drug screen positive | Ethanol | Cocaine | THC | Barbiturates | Amphetamines | Benzodiazepines | Opiates
Item
a positive urine drug screen including ethanol, cocaine, thc, barbiturates, amphetamines, benzodiazepines, and opiates.
boolean
C0743300 (UMLS CUI [1])
C0001962 (UMLS CUI [2])
C0009170 (UMLS CUI [3])
C0039663 (UMLS CUI [4])
C0004745 (UMLS CUI [5])
C0002667 (UMLS CUI [6])
C0005064 (UMLS CUI [7])
C0376196 (UMLS CUI [8])
Alcohol abuse | Illicit drug use | Mental disorders | Physical addiction Opioids | Drug abuse | Drug Dependence
Item
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.
boolean
C0085762 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0278080 (UMLS CUI [4,1])
C0242402 (UMLS CUI [4,2])
C0013146 (UMLS CUI [5])
C1510472 (UMLS CUI [6])
Blood Donation Difficulty with | Blood Donation | Blood product Donation
Item
a history of difficulty with donating blood. donated blood or blood products within 45 days prior to enrollment
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
C0456388 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])