ID

39374

Description

Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01413932

Link

https://clinicaltrials.gov/show/NCT01413932

Keywords

Versions (1)
  1. 1/3/20 1/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Healthy Volunteers (Part 1) NCT01413932

English

Eligibility Healthy Volunteers (Part 1) NCT01413932

1 forms  
Criteria
Description

Criteria

no clinically relevant abnormalities
Description

Abnormality Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
age 18 to 55 years, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) of 18.5 to 32 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
main inclusion criteria (part 2)
Description

Inclusion criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
no clinically relevant abnormalities
Description

Abnormality Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
age 18 to 55 years, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) of 18.5 to 32 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
mild-to-moderate major depressive disorder
Description

Major depressive disorder, mild | Major depressive disorder, moderate

Data type

boolean

Alias
UMLS CUI [1]
C1740001
UMLS CUI [2]
C1741422
main exclusion criteria (part 1)
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
Description

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
main exclusion criteria (part 2)
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
Description

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
current and primary axis i disorder other than mdd
Description

Axis I diagnosis | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
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Similar models

Eligibility Healthy Volunteers (Part 1) NCT01413932

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Abnormality Absent
Item
no clinically relevant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 18 to 55 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18.5 to 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Inclusion criteria Main
Item
main inclusion criteria (part 2)
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Abnormality Absent
Item
no clinically relevant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 18 to 55 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18.5 to 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Major depressive disorder, mild | Major depressive disorder, moderate
Item
mild-to-moderate major depressive disorder
boolean
C1740001 (UMLS CUI [1])
C1741422 (UMLS CUI [2])
Exclusion Criteria Main
Item
main exclusion criteria (part 1)
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination
Item
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Exclusion Criteria Main
Item
main exclusion criteria (part 2)
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination
Item
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Axis I diagnosis | Exception Major Depressive Disorder
Item
current and primary axis i disorder other than mdd
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
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