ID

24012

Description

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation parts: Demography, Medical History and Physical Examination

Keywords

Versions (1)
  1. 7/22/17 7/22/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 22, 2017

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License

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

English

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

1 forms  
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

race

Data type

text

Alias
UMLS CUI [1]
C0034510
other race
Description

race

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

bmi

Data type

float

Measurement units
  • kg/m²
Alias
UMLS CUI [1]
C1305855
kg/m²
Significant medical/surgical history
Description

Significant medical/surgical history

Alias
UMLS CUI-1
C0262926
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
Description

medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0012634
Diagnosis
Description

diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
year of first diagnosis
Description

year of first diagnosis

Data type

text

Measurement units
  • Month/Year
Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Month/Year
Past/Ongoing
Description

ongoing disease

Data type

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date
Description

physical examination date

Data type

date

Alias
UMLS CUI [1]
C2826643
Time
Description

physical examintation time

Data type

time

Alias
UMLS CUI [1]
C2826761
Was the physical examination?
Description

physical examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Record below:
Description

physical examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Study time
Description

study time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual Time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
respiratory rate
Description

respiratory rate

Data type

integer

Alias
UMLS CUI [1]
C0231832
12-Lead ECG Monitoring
Description

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study time
Description

study time

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0040223
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual time
Description

time

Data type

time

Alias
UMLS CUI [1]
C0040223
Heart Rate
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Description

pr duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Description

qrs duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880451
msec
QT
Description

qt duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Description

qtc duration

Data type

float

Alias
UMLS CUI [1]
C0860814
ECG normal?
Description

ecg normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Description

ecg comment

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
gender
Code List
Gender
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
race
Code List
Race
CL Item
American Hispanic (American Hispanic)
CL Item
Arabic/North African (Arabic/North African)
CL Item
Black (Black)
CL Item
East & South East Asia (East & South East Asia)
CL Item
Japanese (Japanese)
CL Item
South Asia (South Asia)
CL Item
White/Caucasian (White/Caucasian)
CL Item
Other (Other)
race
Item
other race
text
C0034510 (UMLS CUI [1])
height
Item
Height
integer
C0005890 (UMLS CUI [1])
weight
Item
Weight
float
C0005910 (UMLS CUI [1])
bmi
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Significant medical/surgical history
C0262926 (UMLS CUI-1)
medical condition
Item
Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0012634 (UMLS CUI [1])
diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
year of first diagnosis
Item
text
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Past/Ongoing
text
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
ongoing disease
Code List
Past/Ongoing
CL Item
Past (Past)
CL Item
Ongoing (Ongoing)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
physical examination date
Item
Date
date
C2826643 (UMLS CUI [1])
physical examintation time
Item
Time
time
C2826761 (UMLS CUI [1])
Item
Was the physical examination?
text
C0031809 (UMLS CUI [1])
physical examination
Code List
Was the physical examination?
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
physical examination
Item
Record below:
text
C0031809 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Study time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
study time
Code List
Study time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
date
Item
Date
date
C0011008 (UMLS CUI [1])
time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
systolic blood pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
integer
C0231832 (UMLS CUI [1])
Item Group
12-Lead ECG Monitoring
C0430456 (UMLS CUI-1)
Item
Study time
text
C2348563 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
study time
Code List
Study time
CL Item
Screening (Screening)
CL Item
Unscheduled (Unscheduled)
date
Item
Date
date
C0011008 (UMLS CUI [1])
time
Item
Actual time
time
C0040223 (UMLS CUI [1])
heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
pr duration
Item
PR
float
C1880446 (UMLS CUI [1])
qrs duration
Item
QRS
float
C1880451 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc duration
Item
QTC
float
C0860814 (UMLS CUI [1])
ecg normal
Item
ECG normal?
boolean
C0522054 (UMLS CUI [1])
ecg comment
Item
Comments
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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