Gender | Japanese | Healthy | Physical Examination | Electrocardiography | Vital signs | Hematologic Tests | Urinalysis
Item
male or female japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine
boolean
C0079399 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0018941 (UMLS CUI [7])
C0042014 (UMLS CUI [8])
Body mass index
Item
body mass index in the range 18.0-25.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to use reliable contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed consent
Item
able to give fully informed written consent.
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Sex Behavior Childbearing Potential Contraceptive methods Not used
Item
pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
C0445107 (UMLS CUI [3,5])
abnormal findings Relevant Clinical
Item
clinically relevant abnormal findings at the screening assessment
boolean
C0159131 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Vital signs Clinical Significance
Item
clinically significant vital signs outside the acceptable range at screening
boolean
C0518766 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Medical History Abnormal Relevant Clinical | Operative Surgical Procedures Abnormal Relevant Clinical | medical condition Abnormal Relevant Clinical
Item
clinically relevant abnormal medical history, surgery or concurrent medical condition
boolean
C0262926 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C2347946 (UMLS CUI [3,3])
C0205210 (UMLS CUI [3,4])
Acute illness | Chronic disease
Item
acute or chronic illness
boolean
C4061114 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate less than 80 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Adverse reaction to drug Severe | Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component
Item
severe adverse reaction to any drug or sensitivity to the trial medication or its components
boolean
C0041755 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Food Allergy Significant | Vegetarian | Vegan
Item
significant food allergy; vegetarian or vegan
boolean
C0016470 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0042441 (UMLS CUI [2])
C2987738 (UMLS CUI [3])
Vitamins | Herbal medicine | Drugs, Non-Prescription | Acetaminophen | Prescribed medications
Item
use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
boolean
C0042890 (UMLS CUI [1])
C2240391 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0000970 (UMLS CUI [4])
C3166216 (UMLS CUI [5])
Study Subject Participation Status Illicit Drugs | Study Subject Participation Status Prescribed medications | Blood Loss
Item
participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 ml blood, within the 3 months before first dose of trial medication
boolean
C2348568 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C3166216 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Cigarette smoker
Item
smoking of more than 5 cigarettes daily
boolean
C0337667 (UMLS CUI [1])
Compliance behavior Limited
Item
possibility that subject will not cooperate
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity
Item
positive test for hepatitis b & c, hiv
boolean
C1608966 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
doubt General Practitioner
Item
objection by a general practitioner.
boolean
C0870444 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])