ID

24500

Beschreibung

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 part: Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

Stichworte

Versionen (1)
  1. 03.08.17 03.08.17 -
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GlaxoSmithKline

Hochgeladen am

3. August 2017

DOI

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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

Englisch

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

1 Formulare  
Dextrometorphan Urine Collection (0-8 hrs)
Beschreibung

Dextrometorphan Urine Collection (0-8 hrs)

Alias
UMLS CUI-1
C0200354
Start Date and Time
Beschreibung

urine collection start date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C3897500
Stop Date and Time
Beschreibung

urine collection stop date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C1264639
Volume of Urine
Beschreibung

urine volume

Datentyp

text

Alias
UMLS CUI [1]
C1287298
Result
Beschreibung

urine flow

Datentyp

float

Maßeinheiten
  • mL/min
Alias
UMLS CUI [1]
C0232851
mL/min
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Study Time
Beschreibung

study time

Datentyp

text

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

vital signs date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Actua Time
Beschreibung

vital signs time

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Systolic BP
Beschreibung

systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Beschreibung

diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
HR
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG Monitoring
Beschreibung

12-Lead ECG Monitoring

Alias
UMLS CUI-1
C0430456
Study Time
Beschreibung

study time

Datentyp

text

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

ecg date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Actual Time
Beschreibung

ecg time

Datentyp

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart Rate (bpm)
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschreibung

pr duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1880446
msec
QRS
Beschreibung

qrs duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Beschreibung

qt duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C1880452
msec
QTC
Beschreibung

qtc interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG Normal?
Beschreibung

ecg normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
Comments
Beschreibung

ecg comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
Clinical Chemistry And Haematology
Beschreibung

Clinical Chemistry And Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date and time of blood sampling
Beschreibung

blood sampling date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Beschreibung

comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Beschreibung

clinical chemistry and hematology normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0205307
Urinanalysis
Beschreibung

Urinanalysis

Alias
UMLS CUI-1
C0042014
Exact date and time of urine sampling
Beschreibung

urine sampling date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Comments:
Beschreibung

comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
Beschreibung

urinanalysis normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205307
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Ähnliche Modelle

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Dextrometorphan Urine Collection (0-8 hrs)
C0200354 (UMLS CUI-1)
urine collection start date and time
Item
Start Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
urine collection stop date and time
Item
Stop Date and Time
datetime
C0200354 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
urine volume
Item
Volume of Urine
text
C1287298 (UMLS CUI [1])
urine flow
Item
Result
float
C0232851 (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
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
vital signs date
Item
Date
date
C2826644 (UMLS CUI [1])
vital signs time
Item
Actua Time
time
C2826762 (UMLS CUI [1])
systolic blood pressure
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
heart rate
Item
HR
integer
C0018810 (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
Pre-dose (Pre-dose)
CL Item
+0.5 hrs (+0.5 hrs)
CL Item
+1 hrs (+1 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
CL Item
Unscheduled (Unscheduled)
ecg date
Item
Date
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ecg time
Item
Actual Time
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart Rate (bpm)
integer
C0018810 (UMLS CUI [1])
pr duration
Item
PR
float
C1880446 (UMLS CUI [1])
qrs duration
Item
QRS
float
C0429025 (UMLS CUI [1])
qt duration
Item
QT
float
C1880452 (UMLS CUI [1])
qtc interval
Item
QTC
float
C0855331 (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])
Item Group
Clinical Chemistry And Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
blood sampling date and time
Item
Exact date and time of blood sampling
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
clinical chemistry and hematology normal
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0008000 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item Group
Urinanalysis
C0042014 (UMLS CUI-1)
urine sampling date and time
Item
Exact date and time of urine sampling
datetime
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
comment
Item
Comments:
text
C0947611 (UMLS CUI [1])
urinanalysis normal
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
boolean
C0042014 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
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