ID

38720

Beskrivning

Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function; ODM derived from: https://clinicaltrials.gov/show/NCT01478399

Länk

https://clinicaltrials.gov/show/NCT01478399

Nyckelord

Versioner (1)
  1. 2019-10-30 2019-10-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01478399

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT01478399

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females age 18 - 79 years of age inclusive.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
bmi 19 - 40 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
renally impaired subjects: in otherwise stable health except for renal disease.
Beskrivning

Study Subject Renal Insufficiency | Health Stable | Exception Kidney Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1565489
UMLS CUI [2,1]
C0018684
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0022658
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.
Beskrivning

Healthy Volunteers | GFR estimation by MDRD | Matching Study Subject Renal Insufficiency | Age | Body Weight | Body mass index | Racial group | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C2170215
UMLS CUI [3,1]
C0150103
UMLS CUI [3,2]
C0681850
UMLS CUI [3,3]
C1565489
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0005910
UMLS CUI [6]
C1305855
UMLS CUI [7]
C0034510
UMLS CUI [8]
C0079399
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.
Beskrivning

Study Subject Renal Insufficiency | Estimated Glomerular Filtration Rate Separate Quantity | Stable status Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1565489
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C0443299
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205210
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.
Beskrivning

Normal Laboratory Test Result | Admission Evaluation Normal | Exception Test Result Consistent with Renal Insufficiency | Exception Test Result Consistent with Kidney Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0438214
UMLS CUI [2,1]
C0582948
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0205307
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0456984
UMLS CUI [3,3]
C0332290
UMLS CUI [3,4]
C1565489
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0456984
UMLS CUI [4,3]
C0332290
UMLS CUI [4,4]
C0022658
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently taking or have taken a glp -1 agent (e.g., byetta®, victoza®) within the past year.
Beskrivning

GLP-1 Receptor Agonist | Byetta | Victoza

Datatyp

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1636686
UMLS CUI [3]
C2732208
subjects who have previously received pb1023.
Beskrivning

Other Coding | GLP-1 Analogue Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C3273809
UMLS CUI [2,2]
C0205369
known allergy or serious adverse effect to an approved or investigational glp-1 receptor analog/agonist.
Beskrivning

Hypersensitivity GLP-1 Analogue | Adverse effect Serious GLP-1 Analogue | Hypersensitivity GLP-1 Receptor Agonist | Adverse effect Serious GLP-1 Receptor Agonist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3273809
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C3273809
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2917359
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C2917359
serious infection within 60 days of admission.
Beskrivning

Communicable Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
donation or loss of greater than 400 ml of blood 56 days prior to enrollment.
Beskrivning

Blood Donation Amount | Blood Loss Amount

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
unstable cardiovascular disease defined as per protocol.
Beskrivning

Cardiovascular Disease Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
clinically significant hepatic dysfunction defined as per protocol.
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
female subjects who are pregnant, trying to become pregnant or lactating.
Beskrivning

Pregnancy | Trying to conceive | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0420843
UMLS CUI [3]
C0006147
known history of or active alcohol or drug abuse within 12 months prior to screening or positive alcohol and/or drug screen.
Beskrivning

Substance Use Disorders | Substance Abuse Screening Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0038577
UMLS CUI [2,2]
C1514241
positive for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies.
Beskrivning

HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0281863
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.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Exception Observational Study | Study Subject Participation Status Interferes with Research results

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1518527
UMLS CUI [5,1]
C2348568
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01478399

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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