ID

15452

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02366364

Keywords

versioni (2)
  1. 01/06/16 01/06/16 -
  2. 01/06/16 01/06/16 -
Caricato su

1 giugno 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Major Depressive Disorder NCT02366364

Inglese

Eligibility Major Depressive Disorder NCT02366364

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects
Descrizione

Gender

Tipo di dati

boolean

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

Age

Tipo di dati

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.
Descrizione

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

Tipo di dati

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
Descrizione

Laboratory Procedures | Upper Limit of Normal | Clinical Significance

Tipo di dati

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
Descrizione

Compliance behavior Study Protocol | Informed Consent

Tipo di dati

boolean

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

Exclusion Criteria

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

ID.6

Tipo di dati

boolean

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.
Descrizione

ID.7

Tipo di dati

boolean

current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.
Descrizione

ID.8

Tipo di dati

boolean

current smoker or use of other tobacco products.
Descrizione

ID.9

Tipo di dati

boolean

currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
Descrizione

ID.10

Tipo di dati

boolean

type i or type ii diabetes.
Descrizione

ID.11

Tipo di dati

boolean

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.
Descrizione

ID.12

Tipo di dati

boolean

currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
Descrizione

ID.13

Tipo di dati

boolean

history of allergy, sensitivity, or intolerance to nmdar ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
Descrizione

ID.14

Tipo di dati

boolean

received another investigational drug or device within 30 days of enrollment in this study.
Descrizione

ID.15

Tipo di dati

boolean

previously participated in this study.
Descrizione

ID.16

Tipo di dati

boolean

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.
Descrizione

ID.17

Tipo di dati

boolean

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Similar models

Eligibility Major Depressive Disorder NCT02366364

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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)
ID.6
Item
human immunodeficiency virus (hiv) infection, or hepatitis or other ongoing infectious disease.
boolean
ID.7
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
ID.8
Item
current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.
boolean
ID.9
Item
current smoker or use of other tobacco products.
boolean
ID.10
Item
currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
boolean
ID.11
Item
type i or type ii diabetes.
boolean
ID.12
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
ID.13
Item
currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
boolean
ID.14
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
ID.15
Item
received another investigational drug or device within 30 days of enrollment in this study.
boolean
ID.16
Item
previously participated in this study.
boolean
ID.17
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
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