ID

37036

Description

Comparative Oral Bioavailability Study of MT-1303; ODM derived from: https://clinicaltrials.gov/show/NCT02310048

Link

https://clinicaltrials.gov/show/NCT02310048

Keywords

Versions (1)
  1. 7/1/19 7/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing-remitting Multiple Sclerosis NCT02310048

English

Eligibility Relapsing-remitting Multiple Sclerosis NCT02310048

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
caucasian males aged 18 to 55 years at screening.
Description

Caucasian | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at screening and day -1.
Description

Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Procedures | Healthy Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3898900
UMLS CUI [3,2]
C0022885
UMLS CUI [4,1]
C3898900
UMLS CUI [4,2]
C0392366
a body weight of ≥60 kilograms (kg) and bmi ranging from 18 to 30 kg/m2 at screening or day -1.
Description

Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
Description

Adverse reactions Severe Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparations | Adverse reactions Severe Pharmaceutical Preparations Excipient | Hypersensitivity Pharmaceutical Preparations Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0015237
participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any imp within 12 weeks or five half-lives of the imp before the administration of the imp in this clinical study.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
clinically relevant abnormal medical history, physical findings, or laboratory values at screening or day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the investigator.
Description

Medical History Abnormal Interferes with Clinical trial protocol | ABNORMAL PHYSICAL FINDING Interferes with Clinical trial protocol | Laboratory test result abnormal Interferes with Clinical trial protocol | Medical History Abnormal Interferes with Patient safety | ABNORMAL PHYSICAL FINDING Interferes with Patient safety | Laboratory test result abnormal Interferes with Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2599718
UMLS CUI [2,1]
C0149610
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2599718
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2599718
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0205161
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1113679
UMLS CUI [5,1]
C0149610
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1113679
previous medical history of tuberculosis or in the opinion of the investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
Description

Tuberculosis | Herpes Labialis Recurrent | Pharyngitis Recurrent | Urinary tract infection Recurrent | Diarrhea Recurrent | Dysentery Recurrent | Lower respiratory tract infection Recurrent | Mycoses Recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C0019345
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C0031350
UMLS CUI [3,2]
C2945760
UMLS CUI [4,1]
C0042029
UMLS CUI [4,2]
C2945760
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C2945760
UMLS CUI [6,1]
C0013369
UMLS CUI [6,2]
C2945760
UMLS CUI [7,1]
C0149725
UMLS CUI [7,2]
C2945760
UMLS CUI [8,1]
C0026946
UMLS CUI [8,2]
C2945760
subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the imp(day 1) unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety. slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety.
Description

Pharmaceutical Preparations Systemic | Topical agents | Slow release drug Active

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1710439
UMLS CUI [3,1]
C0011202
UMLS CUI [3,2]
C0205177
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Similar models

Eligibility Relapsing-remitting Multiple Sclerosis NCT02310048

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Caucasian | Gender | Age
Item
caucasian males aged 18 to 55 years at screening.
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Procedures | Healthy Tests
Item
healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at screening and day -1.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C0392366 (UMLS CUI [4,2])
Body Weight | Body mass index
Item
a body weight of ≥60 kilograms (kg) and bmi ranging from 18 to 30 kg/m2 at screening or day -1.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Adverse reactions Severe Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparations | Adverse reactions Severe Pharmaceutical Preparations Excipient | Hypersensitivity Pharmaceutical Preparations Excipient
Item
presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
boolean
C0559546 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0015237 (UMLS CUI [3,4])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs
Item
participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any imp within 12 weeks or five half-lives of the imp before the administration of the imp in this clinical study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Medical History Abnormal Interferes with Clinical trial protocol | ABNORMAL PHYSICAL FINDING Interferes with Clinical trial protocol | Laboratory test result abnormal Interferes with Clinical trial protocol | Medical History Abnormal Interferes with Patient safety | ABNORMAL PHYSICAL FINDING Interferes with Patient safety | Laboratory test result abnormal Interferes with Patient safety
Item
clinically relevant abnormal medical history, physical findings, or laboratory values at screening or day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the investigator.
boolean
C0262926 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2599718 (UMLS CUI [1,4])
C0149610 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2599718 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2599718 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1113679 (UMLS CUI [4,4])
C0149610 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1113679 (UMLS CUI [6,3])
Tuberculosis | Herpes Labialis Recurrent | Pharyngitis Recurrent | Urinary tract infection Recurrent | Diarrhea Recurrent | Dysentery Recurrent | Lower respiratory tract infection Recurrent | Mycoses Recurrent
Item
previous medical history of tuberculosis or in the opinion of the investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
boolean
C0041296 (UMLS CUI [1])
C0019345 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0031350 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0042029 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0011991 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0013369 (UMLS CUI [6,1])
C2945760 (UMLS CUI [6,2])
C0149725 (UMLS CUI [7,1])
C2945760 (UMLS CUI [7,2])
C0026946 (UMLS CUI [8,1])
C2945760 (UMLS CUI [8,2])
Pharmaceutical Preparations Systemic | Topical agents | Slow release drug Active
Item
subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the imp(day 1) unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety. slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study procedures or compromise safety.
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1710439 (UMLS CUI [2])
C0011202 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
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