ID

15453

Beschrijving

Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02366364

Link

https://clinicaltrials.gov/show/NCT02366364

Trefwoorden

Versies (2)
  1. 01-06-16 01-06-16 -
  2. 01-06-16 01-06-16 -
Geüploaded op

1 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02366364

Engels

Eligibility Major Depressive Disorder NCT02366364

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
aged 18 to 55 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
for female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. if of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
Beschrijving

Female Sterilization | Menopause | Contraceptive methods | Childbearing Potential pregnancy blood test Negative | Childbearing Potential Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0025320
UMLS CUI [3]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0850355
UMLS CUI [4,3]
C0205160
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430057
clinical laboratory values <2 times upper limit of normal (uln) or deemed not clinically significant by the investigator
Beschrijving

Laboratory Procedures | Upper Limit of Normal | Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C1519815
UMLS CUI [3]
C2826293
ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
Beschrijving

Compliance behavior Study Protocol | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
human immunodeficiency virus (hiv) infection, or hepatitis or other ongoing infectious disease.
Beschrijving

HIV Infections | Hepatitis | Communicable Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0009450
current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
Beschrijving

Alcohol abuse | Beer | Wine | Spirits

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C2107808
UMLS CUI [3]
C2203276
UMLS CUI [4]
C0301611
current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.
Beschrijving

Substance Use Disorders DSM-IV

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0220952
current smoker or use of other tobacco products.
Beschrijving

Current Smoker | Tobacco use

Datatype

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0543414
currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
Beschrijving

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
type i or type ii diabetes.
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Beschrijving

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
Beschrijving

Take prescription medications | Take non-prescription medications | Phytotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3843193
UMLS CUI [2]
C3843194
UMLS CUI [3]
C0242388
history of allergy, sensitivity, or intolerance to nmdar ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
Beschrijving

Hypersensitivity N-Methyl-D-Aspartate Receptors Ligands | Intolerance to N-Methyl-D-Aspartate Receptors Ligands | Ketamine | Dextromethorphan | Memantine | Methadone | Propoxyphene | ketobemidone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0080093
UMLS CUI [1,3]
C0023688
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0080093
UMLS CUI [2,3]
C0023688
UMLS CUI [3]
C0022614
UMLS CUI [4]
C0011816
UMLS CUI [5]
C0025242
UMLS CUI [6]
C0025605
UMLS CUI [7]
C0033493
UMLS CUI [8]
C0064311
received another investigational drug or device within 30 days of enrollment in this study.
Beschrijving

Investigational New Drugs Other | Investigational Medical Device Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C2346570
UMLS CUI [2,2]
C0205394
previously participated in this study.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) in the option of the investigator or the sponsor's study monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
Beschrijving

Mental disorders | Major Depressive Disorder | Bipolar Disorder | Anxiety | Schizophrenia | Medical condition Interferes with Drug Evaluation | Renal Insufficiency Severe | Hepatic impairment Severe | Liver diseases Severe | Medical condition Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0003467
UMLS CUI [5]
C0036341
UMLS CUI [6,1]
C1699700
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0013175
UMLS CUI [7,1]
C1565489
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0948807
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C1699700
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C0439801
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Similar models

Eligibility Major Depressive Disorder NCT02366364

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male and female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 18 to 55 years
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Menopause | Contraceptive methods | Childbearing Potential pregnancy blood test Negative | Childbearing Potential Urine pregnancy test negative
Item
for female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. if of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
boolean
C0015787 (UMLS CUI [1])
C0025320 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0850355 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])
Laboratory Procedures | Upper Limit of Normal | Clinical Significance
Item
clinical laboratory values <2 times upper limit of normal (uln) or deemed not clinically significant by the investigator
boolean
C0022885 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
C2826293 (UMLS CUI [3])
Compliance behavior Study Protocol | Informed Consent
Item
ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
HIV Infections | Hepatitis | Communicable Diseases
Item
human immunodeficiency virus (hiv) infection, or hepatitis or other ongoing infectious disease.
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Alcohol abuse | Beer | Wine | Spirits
Item
current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
boolean
C0085762 (UMLS CUI [1])
C2107808 (UMLS CUI [2])
C2203276 (UMLS CUI [3])
C0301611 (UMLS CUI [4])
Substance Use Disorders DSM-IV
Item
current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.
boolean
C0038586 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
Current Smoker | Tobacco use
Item
current smoker or use of other tobacco products.
boolean
C3241966 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
type i or type ii diabetes.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix
Item
malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
Take prescription medications | Take non-prescription medications | Phytotherapy
Item
currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
boolean
C3843193 (UMLS CUI [1])
C3843194 (UMLS CUI [2])
C0242388 (UMLS CUI [3])
Hypersensitivity N-Methyl-D-Aspartate Receptors Ligands | Intolerance to N-Methyl-D-Aspartate Receptors Ligands | Ketamine | Dextromethorphan | Memantine | Methadone | Propoxyphene | ketobemidone
Item
history of allergy, sensitivity, or intolerance to nmdar ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
boolean
C0020517 (UMLS CUI [1,1])
C0080093 (UMLS CUI [1,2])
C0023688 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0080093 (UMLS CUI [2,2])
C0023688 (UMLS CUI [2,3])
C0022614 (UMLS CUI [3])
C0011816 (UMLS CUI [4])
C0025242 (UMLS CUI [5])
C0025605 (UMLS CUI [6])
C0033493 (UMLS CUI [7])
C0064311 (UMLS CUI [8])
Investigational New Drugs Other | Investigational Medical Device Other
Item
received another investigational drug or device within 30 days of enrollment in this study.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Study Subject Participation Status
Item
previously participated in this study.
boolean
C2348568 (UMLS CUI [1])
Mental disorders | Major Depressive Disorder | Bipolar Disorder | Anxiety | Schizophrenia | Medical condition Interferes with Drug Evaluation | Renal Insufficiency Severe | Hepatic impairment Severe | Liver diseases Severe | Medical condition Study Subject Participation Status Limited
Item
psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) in the option of the investigator or the sponsor's study monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
boolean
C0004936 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0003467 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C1699700 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0013175 (UMLS CUI [6,3])
C1565489 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0948807 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C1699700 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C0439801 (UMLS CUI [10,3])
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