ID

23911

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: Eligibility Checklist

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  1. 17-07-17 17-07-17 -
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GlaxoSmithKline

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17 juli 2017

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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Eligibility Checklist

Engels

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Eligibility Checklist

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Is the subject healthy?
Beschrijving

Healthy subjects are defined as individuals who are free from clinically significant illness or disease (including dyspepsia and peptic ulcer) as determinated by their medical history (including family), physical examination, laboratory studies and other tests.

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
2. Is the female subject: (1) of non-child-bearing potential (e.g. sugically sterilised at least six months prior to the study or postmenopausal with no regular menstrual bleeding for at least two years prior to the study
Beschrijving

female of childbearing potential

Datatype

boolean

Alias
UMLS CUI [1]
C1960468
2. Is the female subject: (2) using the following combined contraceptive method non-hormone intra-uterine device (IUD) and condoms. Oral contraceptive methods or hormone IUDs must not be used. The contraceptive method have to be used for the entire duration of the participation in the study and up to one month or one complete menstrual cycle, whichever is the longer, after the last dose of study medication.
Beschrijving

contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
3. Did the subject have a negative pregnancy test?
Beschrijving

pregnancy test

Datatype

text

Alias
UMLS CUI [1]
C0032976
4. Does the 12-lead ECG at the pre-study screening show no abnormalities that in the opinion of the Principal Investigator will compromise safety in this study?
Beschrijving

ECG

Datatype

boolean

Alias
UMLS CUI [1]
C1623258
5. Is the subject aged 18-55 years inclusive?
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
6. Does the subject have a body mass index (BMI) between 19-29kg/m² inclusive with weight range of 55-95kg for males and 50-90kg for females?
Beschrijving

bmi, weight

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
7. Is the subject capable of giving informed consent and can comply with the study requirements and timetable?
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
8. Is the study subject able to read, comprehend and record information?
Beschrijving

able to read, comprehend and record information

Datatype

boolean

Alias
UMLS CUI [1]
C0586740
UMLS CUI [2]
C0162340
UMLS CUI [3,1]
C0034869
UMLS CUI [3,2]
C1533716
9. Has a signed and dated written informed consent been obtained from the subject?
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1576874
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. As a result of the medical interview, physical examination or screening investigations, does the physician responisble considers the subject unfit for the study?
Beschrijving

unfit for study

Datatype

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0008972
2. Does the subject or his family have a history of a drug allergy, or other allergy, which in the opinion of the physician responsible contraindicates the subject's participation in the study?
Beschrijving

allergies

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
3. Is the subject currently participating or has participated in a clinical trial with a new chemical entity during the previous 4 months or any other trial during the previous 3 months?
Beschrijving

study participation

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
4. Does the subject have a history psychiatric illness?
Beschrijving

psychiatric illness

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
5. Has the subject donated a unit of blood within the previous month or intends to donate in the month after completing the study?
Beschrijving

blood donation

Datatype

boolean

Alias
UMLS CUI [1]
C0005794
6. Is the subject a poor metaboliser for CYP2D6?
Beschrijving

cyp2d6 poor metaboliser

Datatype

boolean

Alias
UMLS CUI [1]
C3888904
7. Is the subject currently taking regular (or a course of) medication whether prescibed or not, including vitamins and herbal remedies, such as St John's Wort? Concurrent medication will not be permitted for 48 h before admission to the Unit until the end of the study period (post-study scrren).
Beschrijving

medication

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
8. Does the subject drink on average more than 4 units of alcohol per day?
Beschrijving

alcohol consumption

Datatype

boolean

Alias
UMLS CUI [1]
C0001948
9. Does the subject smoke or has smoked or has used any nicotine-containing products in the last 3 months?
Beschrijving

smoking

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
10. Is the subject unable to abstain from strenuous physical activity for 24 h prior to screening and for 24 h prior tp and 48 h after each treatment period?
Beschrijving

abstain strenuous physical activity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0039475
11. Has the subject tested positive for hepatitis C antibody or hepatitis B surface antigen?
Beschrijving

hepatitis C antibody, hepatitis B surface antigen

Datatype

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0019168
12. Has the subject tested positive for HIV?
Beschrijving

hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
13. Does the subject have a past history of drug abuse or has tested positive for urine drugs of abuse at pre-study screening?
Beschrijving

drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
14. Has the subject been using prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety?
Beschrijving

medication

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
15. Has the subject had a medication within 14 days prior to the first dose of study drugs, which is known to interfere with CYP2D6 or CYP3A isozymes (see Appendix2: Inhibitors and inducers od Cytochrome P450 2D6 and 3A.) or is as an inducer of phase-I or phase-II enzymes such as antiepileptic drugs (e.g., carbamazepine, phenytoin), barbiturates or rifampin?
Beschrijving

medication interaction with cyp enzymes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0687133
UMLS CUI [1,2]
C0057223
UMLS CUI [1,3]
C0059563
16. Has the subject consumed red wine, grapefruit or grapefruit juice and/or chinine-containing beverages within seven days before the first dosing? These foods are known inhibitors of the CYP3A4 or CYP2D6 enzyme system.
Beschrijving

cyp3a4 or cyp2d6 inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3850058
17. Does the subject have a known or suspected perosnal history or family history of adverse reactions or hypersensitivity to Dextromethorphan or Midazolam-like substances?
Beschrijving

history of adverse reactions to dextromethorphan- or midazolam-like substances

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0559546
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C0011816
UMLS CUI [1,5]
C0026056
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0559546
UMLS CUI [2,3]
C0020517
UMLS CUI [2,4]
C0011816
UMLS CUI [2,5]
C0026056
18. Does the subject have an existance of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug?
Beschrijving

medical condition interaction with drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0687133
19. Does the female subject intend to get pregnant or male subject intend to father a child during the three months following the study.
Beschrijving

pregnancy, fathering

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0015671
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Similar models

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Eligibility Checklist

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
healthy subject
Item
1. Is the subject healthy?
boolean
C1708335 (UMLS CUI [1])
female of childbearing potential
Item
2. Is the female subject: (1) of non-child-bearing potential (e.g. sugically sterilised at least six months prior to the study or postmenopausal with no regular menstrual bleeding for at least two years prior to the study
boolean
C1960468 (UMLS CUI [1])
contraception
Item
2. Is the female subject: (2) using the following combined contraceptive method non-hormone intra-uterine device (IUD) and condoms. Oral contraceptive methods or hormone IUDs must not be used. The contraceptive method have to be used for the entire duration of the participation in the study and up to one month or one complete menstrual cycle, whichever is the longer, after the last dose of study medication.
boolean
C0700589 (UMLS CUI [1])
Item
3. Did the subject have a negative pregnancy test?
text
C0032976 (UMLS CUI [1])
pregnancy test
Code List
3. Did the subject have a negative pregnancy test?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
ECG
Item
4. Does the 12-lead ECG at the pre-study screening show no abnormalities that in the opinion of the Principal Investigator will compromise safety in this study?
boolean
C1623258 (UMLS CUI [1])
age
Item
5. Is the subject aged 18-55 years inclusive?
boolean
C0001779 (UMLS CUI [1])
bmi, weight
Item
6. Does the subject have a body mass index (BMI) between 19-29kg/m² inclusive with weight range of 55-95kg for males and 50-90kg for females?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
informed consent
Item
7. Is the subject capable of giving informed consent and can comply with the study requirements and timetable?
boolean
C0021430 (UMLS CUI [1])
able to read, comprehend and record information
Item
8. Is the study subject able to read, comprehend and record information?
boolean
C0586740 (UMLS CUI [1])
C0162340 (UMLS CUI [2])
C0034869 (UMLS CUI [3,1])
C1533716 (UMLS CUI [3,2])
written informed consent
Item
9. Has a signed and dated written informed consent been obtained from the subject?
boolean
C0021430 (UMLS CUI [1,1])
C1576874 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
unfit for study
Item
1. As a result of the medical interview, physical examination or screening investigations, does the physician responisble considers the subject unfit for the study?
boolean
C3841806 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
allergies
Item
2. Does the subject or his family have a history of a drug allergy, or other allergy, which in the opinion of the physician responsible contraindicates the subject's participation in the study?
boolean
C0020517 (UMLS CUI [1])
study participation
Item
3. Is the subject currently participating or has participated in a clinical trial with a new chemical entity during the previous 4 months or any other trial during the previous 3 months?
boolean
C2348568 (UMLS CUI [1])
psychiatric illness
Item
4. Does the subject have a history psychiatric illness?
boolean
C0004936 (UMLS CUI [1])
blood donation
Item
5. Has the subject donated a unit of blood within the previous month or intends to donate in the month after completing the study?
boolean
C0005794 (UMLS CUI [1])
cyp2d6 poor metaboliser
Item
6. Is the subject a poor metaboliser for CYP2D6?
boolean
C3888904 (UMLS CUI [1])
medication
Item
7. Is the subject currently taking regular (or a course of) medication whether prescibed or not, including vitamins and herbal remedies, such as St John's Wort? Concurrent medication will not be permitted for 48 h before admission to the Unit until the end of the study period (post-study scrren).
boolean
C0013227 (UMLS CUI [1])
alcohol consumption
Item
8. Does the subject drink on average more than 4 units of alcohol per day?
boolean
C0001948 (UMLS CUI [1])
smoking
Item
9. Does the subject smoke or has smoked or has used any nicotine-containing products in the last 3 months?
boolean
C0543414 (UMLS CUI [1])
abstain strenuous physical activity
Item
10. Is the subject unable to abstain from strenuous physical activity for 24 h prior to screening and for 24 h prior tp and 48 h after each treatment period?
boolean
C1514989 (UMLS CUI [1,1])
C0039475 (UMLS CUI [1,2])
hepatitis C antibody, hepatitis B surface antigen
Item
11. Has the subject tested positive for hepatitis C antibody or hepatitis B surface antigen?
boolean
C0281863 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
hiv
Item
12. Has the subject tested positive for HIV?
boolean
C0019682 (UMLS CUI [1])
drug abuse
Item
13. Does the subject have a past history of drug abuse or has tested positive for urine drugs of abuse at pre-study screening?
boolean
C0013146 (UMLS CUI [1])
medication
Item
14. Has the subject been using prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety?
boolean
C0013227 (UMLS CUI [1])
medication interaction with cyp enzymes
Item
15. Has the subject had a medication within 14 days prior to the first dose of study drugs, which is known to interfere with CYP2D6 or CYP3A isozymes (see Appendix2: Inhibitors and inducers od Cytochrome P450 2D6 and 3A.) or is as an inducer of phase-I or phase-II enzymes such as antiepileptic drugs (e.g., carbamazepine, phenytoin), barbiturates or rifampin?
boolean
C0687133 (UMLS CUI [1,1])
C0057223 (UMLS CUI [1,2])
C0059563 (UMLS CUI [1,3])
cyp3a4 or cyp2d6 inhibitors
Item
16. Has the subject consumed red wine, grapefruit or grapefruit juice and/or chinine-containing beverages within seven days before the first dosing? These foods are known inhibitors of the CYP3A4 or CYP2D6 enzyme system.
boolean
C3830624 (UMLS CUI [1])
C3850058 (UMLS CUI [2])
history of adverse reactions to dextromethorphan- or midazolam-like substances
Item
17. Does the subject have a known or suspected perosnal history or family history of adverse reactions or hypersensitivity to Dextromethorphan or Midazolam-like substances?
boolean
C0262926 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0011816 (UMLS CUI [1,4])
C0026056 (UMLS CUI [1,5])
C0241889 (UMLS CUI [2,1])
C0559546 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0011816 (UMLS CUI [2,4])
C0026056 (UMLS CUI [2,5])
medical condition interaction with drug
Item
18. Does the subject have an existance of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug?
boolean
C0012634 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
pregnancy, fathering
Item
19. Does the female subject intend to get pregnant or male subject intend to father a child during the three months following the study.
boolean
C0032961 (UMLS CUI [1])
C0015671 (UMLS CUI [2])
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