ID

24050

Descrizione

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: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Keywords

versioni (2)
  1. 24/07/17 24/07/17 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

24 luglio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

Inglese

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

1 moduli  
Pharmacogenetic Research
Descrizione

Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for Pharmacogenetic Research?
Descrizione

consent for pharmacogenetic research

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
If Yes, record the date informed consent obtained for Pharmacogenetic Research
Descrizione

consent for pharmacogenetic research date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If No, check one reason:
Descrizione

consent for pharmacogenetic research reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Specify other:
Descrizione

consent for pharmacogenetic research reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Has a blood sample been collected for Pharmacogenetic Research?
Descrizione

blood sample collection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, record the date the sample was taken:
Descrizione

blood sample collection date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Has this subject withdrwan consent for Pharmacogenetic Research?
Descrizione

withdrawal of consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1707492
Has a request been made for sample destruction?
Descrizione

blood sample destruction

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes, check one reason:
Descrizione

blood sample destruction reason

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Specify other:
Descrizione

blood sample destruction reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Prior Medication
Descrizione

Prior Medication

Alias
UMLS CUI-1
C0013227
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Descrizione

If Yes, please record the medications below.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013227
Drug Name (Trade Name Preferred)
Descrizione

drug name

Tipo di dati

text

Alias
UMLS CUI [1]
C0013227
Single Dose/Unit (e.g. 500mg)
Descrizione

dosage

Tipo di dati

text

Alias
UMLS CUI [1]
C0178602
Frequency of this Dose (e.g. BID, PRN)
Descrizione

frequency of this dose

Tipo di dati

text

Alias
UMLS CUI [1]
C3476109
Route
Descrizione

administration route

Tipo di dati

text

Alias
UMLS CUI [1]
C0013153
Indication
Descrizione

medication indication

Tipo di dati

text

Alias
UMLS CUI [1]
C3146298
Duration of Therapy (e.g. 6 years)
Descrizione

duration of therapy

Tipo di dati

text

Alias
UMLS CUI [1]
C0444917
End Date
Descrizione

medication end date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Continuing at end of study?
Descrizione

continuing medication at end of study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1553904
Baseline Signs Ans Symptoms
Descrizione

Baseline Signs Ans Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline Sign/Symptom
Descrizione

diagnosis

Tipo di dati

text

Alias
UMLS CUI [1]
C0011900
Onset Date and Time
Descrizione

onset date and time

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C2981441
UMLS CUI [1,2]
C1442488
End Date and Time
Descrizione

end date and time

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C2981425
UMLS CUI [1,2]
C1442488
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
Descrizione

outcome

Tipo di dati

text

Alias
UMLS CUI [1]
C1705586
Event Course
Descrizione

event course

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity
Descrizione

intensity

Tipo di dati

text

Alias
UMLS CUI [1]
C0518690
Relationship to study procedures performed prior to randomisation
Descrizione

relationship to study procedures

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510821
Corrective Therapy
Descrizione

If Yes, please record on Prior Medication form.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Descrizione

subject withdrawn due to event

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Pharmacogenetic Research
C0031325 (UMLS CUI-1)
consent for pharmacogenetic research
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
consent for pharmacogenetic research date
Item
If Yes, record the date informed consent obtained for Pharmacogenetic Research
date
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, check one reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
consent for pharmacogenetic research reason
Code List
If No, check one reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (0)
consent for pharmacogenetic research reason
Item
Specify other:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
blood sample collection
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C0005834 (UMLS CUI [1])
blood sample collection date
Item
If Yes, record the date the sample was taken:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
withdrawal of consent
Item
Has this subject withdrwan consent for Pharmacogenetic Research?
boolean
C1707492 (UMLS CUI [1])
blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason:
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
blood sample destruction reason
Code List
If Yes, check one reason:
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other (0)
blood sample destruction reason
Item
Specify other:
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Prior Medication
C0013227 (UMLS CUI-1)
prior medication
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C0013227 (UMLS CUI [1])
drug name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
dosage
Item
Single Dose/Unit (e.g. 500mg)
text
C0178602 (UMLS CUI [1])
frequency of this dose
Item
Frequency of this Dose (e.g. BID, PRN)
text
C3476109 (UMLS CUI [1])
administration route
Item
Route
text
C0013153 (UMLS CUI [1])
medication indication
Item
Indication
text
C3146298 (UMLS CUI [1])
duration of therapy
Item
Duration of Therapy (e.g. 6 years)
text
C0444917 (UMLS CUI [1])
medication end date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
continuing medication at end of study
Item
Continuing at end of study?
boolean
C1553904 (UMLS CUI [1])
Item Group
Baseline Signs Ans Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
diagnosis
Item
Baseline Sign/Symptom
text
C0011900 (UMLS CUI [1])
onset date and time
Item
Onset Date and Time
datetime
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
end date and time
Item
End Date and Time
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
text
C1705586 (UMLS CUI [1])
outcome
Code List
Outcome (If yubject dies, please inform GSK within 24 hours and complete form D)
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
event course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
Item
Intensity
text
C0518690 (UMLS CUI [1])
intensity
Code List
Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Relationship to study procedures performed prior to randomisation
text
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
relationship to study procedures
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Suspected)
CL Item
Probable (Probable)
corrective therapy
Item
Corrective Therapy
boolean
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn due to event
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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