Age
Item
males and females age 18 - 79 years of age inclusive.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi 19 - 40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Study Subject Renal Insufficiency | Health Stable | Exception Kidney Disease
Item
renally impaired subjects: in otherwise stable health except for renal disease.
boolean
C0681850 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
C0018684 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0022658 (UMLS CUI [3,2])
Healthy Volunteers | GFR estimation by MDRD | Matching Study Subject Renal Insufficiency | Age | Body Weight | Body mass index | Racial group | Gender
Item
healthy volunteers must have/be: egfr as calculated by mdrd of ≥ 80 ml/min, and matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible bmi, race and gender.
boolean
C1708335 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0150103 (UMLS CUI [3,1])
C0681850 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
C0001779 (UMLS CUI [4])
C0005910 (UMLS CUI [5])
C1305855 (UMLS CUI [6])
C0034510 (UMLS CUI [7])
C0079399 (UMLS CUI [8])
Study Subject Renal Insufficiency | Estimated Glomerular Filtration Rate Separate Quantity | Stable status Clinical
Item
subjects with renal impairment must have 2 separate egfr that are within 20% of each other and clinically stable for a minimum of 6 months.
boolean
C0681850 (UMLS CUI [1,1])
C1565489 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C0443299 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
Normal Laboratory Test Result | Admission Evaluation Normal | Exception Test Result Consistent with Renal Insufficiency | Exception Test Result Consistent with Kidney Disease
Item
no clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the investigator.
boolean
C0438214 (UMLS CUI [1])
C0582948 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0456984 (UMLS CUI [3,2])
C0332290 (UMLS CUI [3,3])
C1565489 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0456984 (UMLS CUI [4,2])
C0332290 (UMLS CUI [4,3])
C0022658 (UMLS CUI [4,4])
GLP-1 Receptor Agonist | Byetta | Victoza
Item
currently taking or have taken a glp -1 agent (e.g., byetta®, victoza®) within the past year.
boolean
C2917359 (UMLS CUI [1])
C1636686 (UMLS CUI [2])
C2732208 (UMLS CUI [3])
Other Coding | GLP-1 Analogue Specified
Item
subjects who have previously received pb1023.
boolean
C3846158 (UMLS CUI [1])
C3273809 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Hypersensitivity GLP-1 Analogue | Adverse effect Serious GLP-1 Analogue | Hypersensitivity GLP-1 Receptor Agonist | Adverse effect Serious GLP-1 Receptor Agonist
Item
known allergy or serious adverse effect to an approved or investigational glp-1 receptor analog/agonist.
boolean
C0020517 (UMLS CUI [1,1])
C3273809 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3273809 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C2917359 (UMLS CUI [3,2])
C0879626 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2917359 (UMLS CUI [4,3])
Communicable Disease Serious
Item
serious infection within 60 days of admission.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Blood Donation Amount | Blood Loss Amount
Item
donation or loss of greater than 400 ml of blood 56 days prior to enrollment.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Cardiovascular Disease Unstable
Item
unstable cardiovascular disease defined as per protocol.
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Liver Dysfunction
Item
clinically significant hepatic dysfunction defined as per protocol.
boolean
C0086565 (UMLS CUI [1])
Pregnancy | Trying to conceive | Breast Feeding
Item
female subjects who are pregnant, trying to become pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0420843 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Substance Use Disorders | Substance Abuse Screening Positive
Item
known history of or active alcohol or drug abuse within 12 months prior to screening or positive alcohol and/or drug screen.
boolean
C0038586 (UMLS CUI [1])
C0038577 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
positive for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies.
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0281863 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Exception Observational Study | Study Subject Participation Status Interferes with Research results
Item
participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the investigator would interfere with the outcome of the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1518527 (UMLS CUI [4,2])
C2348568 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])