ID

36465

Description

A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults; ODM derived from: https://clinicaltrials.gov/show/NCT02201849

Link

https://clinicaltrials.gov/show/NCT02201849

Keywords

Versions (1)
  1. 5/16/19 5/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02201849

English

Eligibility Multiple Sclerosis NCT02201849

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a body-mass index (bmi) >/=18.0 and </=32.0 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
Description

Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
additional criteria may apply
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is currently pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
has a lifetime history of menopausal hot flashes
Description

Hot flushes Lifetime

Data type

boolean

Alias
UMLS CUI [1,1]
C0600142
UMLS CUI [1,2]
C4071830
has a clinically significant medical condition
Description

Medical condition Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826293
has had a clinically significant illness in the 30 days prior to first study drug administration
Description

Illness Clinical Significance Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332185
has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
Description

Communicable Disease Serious | Pneumonia | Septicemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0032285
UMLS CUI [3]
C0036690
has had any vaccinations in the 4 weeks prior to inpatient admission
Description

Vaccination | Status pre- Inpatient Admission

Data type

boolean

Alias
UMLS CUI [1]
C0042196
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0021562
UMLS CUI [2,3]
C0809949
has a lifetime history of diabetes
Description

Diabetes Mellitus Lifetime

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C4071830
additional criteria may apply
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis NCT02201849

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
has a body-mass index (bmi) >/=18.0 and </=32.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Use of Contraceptive methods
Item
agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Inclusion criteria Additional
Item
additional criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
is currently pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hot flushes Lifetime
Item
has a lifetime history of menopausal hot flashes
boolean
C0600142 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Medical condition Clinical Significance
Item
has a clinically significant medical condition
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Illness Clinical Significance Recent
Item
has had a clinically significant illness in the 30 days prior to first study drug administration
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Communicable Disease Serious | Pneumonia | Septicemia
Item
has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C0036690 (UMLS CUI [3])
Vaccination | Status pre- Inpatient Admission
Item
has had any vaccinations in the 4 weeks prior to inpatient admission
boolean
C0042196 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0021562 (UMLS CUI [2,2])
C0809949 (UMLS CUI [2,3])
Diabetes Mellitus Lifetime
Item
has a lifetime history of diabetes
boolean
C0011849 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Exclusion Criteria Additional
Item
additional criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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