ID

37025

Description

Mass Balance Study of MT-1303; ODM derived from: https://clinicaltrials.gov/show/NCT02293967

Link

https://clinicaltrials.gov/show/NCT02293967

Keywords

  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 NCT02293967

Eligibility Relapsing-remitting Multiple Sclerosis NCT02293967

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
caucasian male aged 30 to 65 at screening.
Description

Caucasian | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
body weight of ≥60 kg, and a bmi ranging from 18.0 to 32.0 kg/m2 at screening and day-1.
Description

Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
normal or not clinically significant ecg as defined by a hr between 50 and 100 bpm inclusive at screening, day -1 and pre-dose.
Description

ECG normal | Heart rate

Data type

boolean

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2]
C0018810
vital signs within the following ranges at screening and day -1,body temperature: 35.0 to 37.5 °c,sbp: 90 to 140 mmhg,dbp: 50 to 90 mmhg.
Description

Vital signs | Body temperature measurement | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0886414
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
regular daily bowel movements.
Description

Bowel movements Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0011135
UMLS CUI [1,2]
C0205272
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 msv in the last 12 months or 10 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study.
Description

Exposure to radiation | Exception Background Radiation | Diagnostic radiologic examination

Data type

boolean

Alias
UMLS CUI [1]
C0015333
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004607
UMLS CUI [3]
C0043299
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 infections.
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
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. the investigator should be guided by evidence of any of the following:
Description

Operative Surgical Procedures Changing Drug absorption | Operative Surgical Procedures Changing Drug distribution | Operative Surgical Procedures Changing Drug metabolism | Operative Surgical Procedures Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Operative Surgical Procedures Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0683141
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C0678745
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C0699903
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0392747
UMLS CUI [7,3]
C0683140
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0392747
UMLS CUI [8,3]
C0683141
UMLS CUI [9,1]
C0543467
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1444641
history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
Description

Inflammatory Bowel Disease | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0017152
UMLS CUI [3]
C0041582
UMLS CUI [4]
C0017181
UMLS CUI [5]
C0267596
history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
Description

Gastrointestinal Surgical Procedure Major | Gastrectomy | Gastroenterostomy | Bowel resection

Data type

boolean

Alias
UMLS CUI [1,1]
C0524722
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0017118
UMLS CUI [3]
C0017164
UMLS CUI [4]
C0741614

Similar models

Eligibility Relapsing-remitting Multiple Sclerosis NCT02293967

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Caucasian | Gender | Age
Item
caucasian male aged 30 to 65 at screening.
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body Weight | Body mass index
Item
body weight of ≥60 kg, and a bmi ranging from 18.0 to 32.0 kg/m2 at screening and day-1.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
ECG normal | Heart rate
Item
normal or not clinically significant ecg as defined by a hr between 50 and 100 bpm inclusive at screening, day -1 and pre-dose.
boolean
C0522054 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Vital signs | Body temperature measurement | Systolic Pressure | Diastolic blood pressure
Item
vital signs within the following ranges at screening and day -1,body temperature: 35.0 to 37.5 °c,sbp: 90 to 140 mmhg,dbp: 50 to 90 mmhg.
boolean
C0518766 (UMLS CUI [1])
C0886414 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Bowel movements Regular
Item
regular daily bowel movements.
boolean
C0011135 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exposure to radiation | Exception Background Radiation | Diagnostic radiologic examination
Item
radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 msv in the last 12 months or 10 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study.
boolean
C0015333 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004607 (UMLS CUI [2,2])
C0043299 (UMLS CUI [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 infections.
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])
Operative Surgical Procedures Changing Drug absorption | Operative Surgical Procedures Changing Drug distribution | Operative Surgical Procedures Changing Drug metabolism | Operative Surgical Procedures Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Operative Surgical Procedures Study Subject Participation Status At risk | Medical condition Study Subject Participation Status At risk
Item
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. the investigator should be guided by evidence of any of the following:
boolean
C0543467 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0678745 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0699903 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0683140 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0392747 (UMLS CUI [8,2])
C0683141 (UMLS CUI [8,3])
C0543467 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Inflammatory Bowel Disease | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage
Item
history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
boolean
C0021390 (UMLS CUI [1])
C0017152 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
C0267596 (UMLS CUI [5])
Gastrointestinal Surgical Procedure Major | Gastrectomy | Gastroenterostomy | Bowel resection
Item
history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
boolean
C0524722 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0017118 (UMLS CUI [2])
C0017164 (UMLS CUI [3])
C0741614 (UMLS CUI [4])

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