ID

24026

Beschrijving

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: Laboratory Collections

Trefwoorden

Versies (1)
  1. 2017-07-23 2017-07-23 -
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GlaxoSmithKline

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23 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

Engels

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

1 Formulieren  
Clinical Chemistry and Haematology
Beschrijving

Clinical Chemistry and Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact date an time of blood sampling
Beschrijving

blood sampling date and time

Datatype

datetime

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

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
Beschrijving

hematology

Datatype

boolean

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

Urinanalysis

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

urine sampling date and time

Datatype

datetime

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

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record on Baseline Signs and Symptoms page.
Beschrijving

urinanalysis normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0205307
Drug Screening (Urine)
Beschrijving

Drug Screening (Urine)

Alias
UMLS CUI-1
C0202274
Exact date and time of urine sampling
Beschrijving

urine sampling date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
Beschrijving

drug screening positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C1446409
Type of drug
Beschrijving

drug type

Datatype

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
HIV and Hepatitis B & C
Beschrijving

HIV and Hepatitis B & C

Alias
UMLS CUI-1
C0019682
UMLS CUI-2
C0019163
UMLS CUI-3
C0019196
Exact date and time of blood sampling
Beschrijving

blood sampling date and time

Datatype

datetime

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

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Alcohol Breath Test
Beschrijving

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Exact date and time of test
Beschrijving

alcohol breath test date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Alcohol breath test positive or negative? If positive please withdraw from the study.
Beschrijving

alcohol breath test

Datatype

text

Alias
UMLS CUI [1]
C0202306
Urine Cotinine Test
Beschrijving

Urine Cotinine Test

Alias
UMLS CUI-1
C1697737
Exact date and time of test
Beschrijving

If positive please withdraw from the study.

Datatype

datetime

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Serum b-HCG Pregnancy Test (Females only)
Beschrijving

Serum b-HCG Pregnancy Test (Females only)

Alias
UMLS CUI-1
C0430060
Was a pregnancy test carried out?
Beschrijving

pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0430060
If NO, please specify reason
Beschrijving

pregnancy test

Datatype

text

Alias
UMLS CUI [1]
C0430060
If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
Beschrijving

pregnancy test date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0430060
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
If YES, please indicate date and time of test and result:
Beschrijving

If POSITIVE, withdraw the subject from the study.

Datatype

text

Alias
UMLS CUI [1]
C0430060
Laboratory name, if applicable
Beschrijving

Ensure result is included on laboratory report

Datatype

text

Alias
UMLS CUI [1]
C1882331
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Clinical Chemistry and Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
blood sampling date and time
Item
Exact date an 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])
hematology
Item
Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms 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 on Baseline Signs and Symptoms page.
boolean
C0042014 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Item Group
Drug Screening (Urine)
C0202274 (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])
drug screening positive
Item
Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
boolean
C0202274 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
drug type
Item
Type of drug
text
C0457591 (UMLS CUI [1])
comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
HIV and Hepatitis B & C
C0019682 (UMLS CUI-1)
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
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])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
alcohol breath test date and time
Item
Exact date and time of test
datetime
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Alcohol breath test positive or negative? If positive please withdraw from the study.
text
C0202306 (UMLS CUI [1])
alcohol breath test
Code List
Alcohol breath test positive or negative? If positive please withdraw from the study.
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Urine Cotinine Test
C1697737 (UMLS CUI-1)
urine cotinine test date and time
Item
Exact date and time of test
datetime
C1697737 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Serum b-HCG Pregnancy Test (Females only)
C0430060 (UMLS CUI-1)
pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0430060 (UMLS CUI [1])
pregnancy test
Item
If NO, please specify reason
text
C0430060 (UMLS CUI [1])
pregnancy test date and time
Item
If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
datetime
C0430060 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
If YES, please indicate date and time of test and result:
text
C0430060 (UMLS CUI [1])
alcohol breath test
Code List
If YES, please indicate date and time of test and result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
laboratory name
Item
Laboratory name, if applicable
text
C1882331 (UMLS CUI [1])
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