ID

24394

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 part: Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

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  1. 7/30/17 7/30/17 -
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GlaxoSmithKline

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July 30, 2017

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Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

English

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 forms  
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Data type

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Comment
Description

pharmacokinetics comment

Data type

text

Alias
UMLS CUI [1]
C0031328
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing GW597599
Description

dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing dextrometorphan
Description

dextrometorphan dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Date and time of dosing Midazolam
Description

midazolam dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0026056
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Dose checked and administered by:
Description

dose administered

Data type

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Description

dose witnessed

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0682356
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Data type

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Description

pharmacokinetics comment

Data type

text

Alias
UMLS CUI [1]
C0031328
PK Sampling
Description

PK Sampling

Alias
UMLS CUI-1
C0031327
Time relative to start of dose
Description

time since dose

Data type

text

Alias
UMLS CUI [1]
C0946444
Date
Description

pharmacokinetics date

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0011008
Actual Time
Description

pharmacokinetics time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Sample Taken
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Comments
Description

pharmacokinetics comment

Data type

text

Alias
UMLS CUI [1]
C0031328
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comment
text
C0031328 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dosing date and time
Item
Date and time of dosing GW597599
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
dextrometorphan dosing date and time
Item
Date and time of dosing dextrometorphan
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
midazolam dosing date and time
Item
Date and time of dosing Midazolam
datetime
C0026056 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
dose administered
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
dose witnessed
Item
Dose checked and witnessed by:
text
C0013227 (UMLS CUI [1,1])
C0682356 (UMLS CUI [1,2])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+1 hr (+1 hr)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+5 hrs (+5 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+16 hrs (+16 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
Item Group
PK Sampling
C0031327 (UMLS CUI-1)
Item
Time relative to start of dose
text
C0946444 (UMLS CUI [1])
time since dose
Code List
Time relative to start of dose
CL Item
Pre-dose (Pre-dose)
CL Item
+5 mins (+5 mins)
CL Item
+0.25 hr (+0.25 hr)
CL Item
+0.5 hr (+0.5 hr)
CL Item
+1 hr (+1 hr)
CL Item
+1.5 hrs (+1.5 hrs)
CL Item
+2 hrs (+2 hrs)
CL Item
+3 hrs (+3 hrs)
CL Item
+4 hrs (+4 hrs)
CL Item
+6 hrs (+6 hrs)
CL Item
+8 hrs (+8 hrs)
CL Item
+12 hrs (+12 hrs)
CL Item
+24 hrs (+24 hrs)
pharmacokinetics date
Item
Date
date
C0031328 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
pharmacokinetics time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
blood sample
Item
Sample Taken
boolean
C0005834 (UMLS CUI [1])
pharmacokinetics comment
Item
Comments
text
C0031328 (UMLS CUI [1])
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