Body Weight | Body mass index
Item
weight of at least 50 kg with body mass index (bmi) between 18 and 30 kg/m2
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Gender | Childbearing Potential Absent
Item
female subjects must be of non-childbearing potential as defined per the protocol
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Gender Partner Childbearing Potential | Gender Contraceptive methods
Item
male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol and directions
boolean
C0525058 (UMLS CUI [1])
Avoidance Consumption Grapefruit | Avoidance Consumption GRAPEFRUIT JUICE | Avoidance Consumption Seville orange Fruit
Item
willing to avoid consumption of grapefruit, grapefruit juice and seville oranges
boolean
C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0995150 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0452456 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0330922 (UMLS CUI [3,3])
C0016767 (UMLS CUI [3,4])
Avoidance Consumption Nicotine | Avoidance Consumption Nicotine Chewing Gum | Avoidance Consumption Alcoholic Beverages
Item
willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
boolean
C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0599654 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0001967 (UMLS CUI [3,3])
Medical condition At risk Patient safety | Operative Surgical Procedure At risk Patient safety | Medical condition Interferes with Study Protocol | Operative Surgical Procedure Interferes with Study Protocol
Item
ongoing or history of any medical or surgical condition that, in the judgment of the investigator, might jeopardize the subject's safety or interfere with the study objectives
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Meningitis | Encephalitis | Seizures | Migraine | Tremor | Myoclonus | Sleep Disorders | Anxiety | Syncope | Craniocerebral Trauma | Family history Seizures
Item
history of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
boolean
C0025289 (UMLS CUI [1])
C0014038 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0149931 (UMLS CUI [4])
C0040822 (UMLS CUI [5])
C0027066 (UMLS CUI [6])
C0851578 (UMLS CUI [7])
C0003467 (UMLS CUI [8])
C0039070 (UMLS CUI [9])
C0018674 (UMLS CUI [10])
C0241889 (UMLS CUI [11,1])
C0036572 (UMLS CUI [11,2])
ECG abnormal | Laboratory test result abnormal | Physical examination abnormal
Item
any abnormal ecg findings, abnormal laboratory value, or physical examination findings at screening judged to be clinically significant
boolean
C0522055 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
Neurological examination abnormal
Item
any abnormal neurological examination findings at screening that is judged as clinically significant
boolean
C1112537 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 12 g/dl
boolean
C0518015 (UMLS CUI [1])
HIV Seropositivity | Serology positive Hepatitis B | Serology positive Hepatitis C
Item
serology test positive for hiv, or hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Urine drug screen positive | Urine cotinine test positive | Urine drug screen ethanol Positive
Item
positive urine drug test (including cotinine or ethanol)
boolean
C0743300 (UMLS CUI [1])
C1699505 (UMLS CUI [2])
C2188602 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Multivitamin preparation | Dietary Supplements | Herbal Supplements
Item
use of systemic prescription medications or over the counter (otc) medication, including multivitamins, and dietary and herbal supplement
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1504473 (UMLS CUI [5])
Investigational New Drugs | Investigational Medical Device
Item
use of any experimental or investigational drug or device within 30 days
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Childbearing Potential | Pregnancy | Breast Feeding
Item
female subjects who are of childbearing potential, pregnant or lactating
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Blood Donation | Blood Loss | Plasma Charitable contribution
Item
donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0032105 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Psychosocial problem | Addictive Behavior
Item
psychosocial or addictive disorders
boolean
C0740697 (UMLS CUI [1])
C0085281 (UMLS CUI [2])