Informações:
Falhas:
ID
14236
Descrição
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males; ODM derived from: https://clinicaltrials.gov/show/NCT00480467
Link
https://clinicaltrials.gov/show/NCT00480467
Palavras-chave
Versões (1)
- 05/04/2016 05/04/2016 -
Transferido a
5 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00480467
Eligibility Alzheimer Disease NCT00480467
- StudyEvent: Eligibility
Similar models
Eligibility Alzheimer Disease NCT00480467
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
man; age; informed consent
Item
men aged 20 to 45 years (inclusive) at the time of getting informed consent.
boolean
C0025266 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
body mass index; weight
Item
body mass index (bmi) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (bmi = [weight (kg)]/[height (m)]2).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0005910 (UMLS CUI [2])
health status; vital signs; ecg; alanine aminotransferase; aspartate aminotransferase; creatinine levels
Item
healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ecg). alanine aminotransferase (alt), aspartate aminotransferase (ast) and creatinine levels must be within the upper limit of normal for eligibility.
boolean
C0018759 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0428279 (UMLS CUI [6])
C0518766 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0428279 (UMLS CUI [6])
cardiovascular disease; Hepatic disease; renal disease; respiratory disease; gastrointenstinal disease; endocrine disease; immunologic disease; dermatologic disease; hematologic disease; neurologic disease; psychiatric disease
Item
any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0037274 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0037274 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
physical examination; vital signs; 12 lead ECG
Item
any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results.
boolean
C0031809 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
C0518766 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
Caffeine coffee; alcohol; grapefruit
Item
consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.
boolean
C0006644 (UMLS CUI [1,1])
C0009237 (UMLS CUI [1,2])
C0001975 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0009237 (UMLS CUI [1,2])
C0001975 (UMLS CUI [2])
C0995150 (UMLS CUI [3])