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23911

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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 luglio 2017

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

    Inglese

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

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

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

    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.

    Tipo di dati

    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
    Descrizione

    female of childbearing potential

    Tipo di dati

    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.
    Descrizione

    contraception

    Tipo di dati

    boolean

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

    pregnancy test

    Tipo di dati

    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?
    Descrizione

    ECG

    Tipo di dati

    boolean

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

    age

    Tipo di dati

    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?
    Descrizione

    bmi, weight

    Tipo di dati

    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?
    Descrizione

    informed consent

    Tipo di dati

    boolean

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

    able to read, comprehend and record information

    Tipo di dati

    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?
    Descrizione

    written informed consent

    Tipo di dati

    boolean

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

    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?
    Descrizione

    unfit for study

    Tipo di dati

    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?
    Descrizione

    allergies

    Tipo di dati

    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?
    Descrizione

    study participation

    Tipo di dati

    boolean

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

    psychiatric illness

    Tipo di dati

    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?
    Descrizione

    blood donation

    Tipo di dati

    boolean

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

    cyp2d6 poor metaboliser

    Tipo di dati

    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).
    Descrizione

    medication

    Tipo di dati

    boolean

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

    alcohol consumption

    Tipo di dati

    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?
    Descrizione

    smoking

    Tipo di dati

    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?
    Descrizione

    abstain strenuous physical activity

    Tipo di dati

    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?
    Descrizione

    hepatitis C antibody, hepatitis B surface antigen

    Tipo di dati

    boolean

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

    hiv

    Tipo di dati

    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?
    Descrizione

    drug abuse

    Tipo di dati

    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?
    Descrizione

    medication

    Tipo di dati

    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?
    Descrizione

    medication interaction with cyp enzymes

    Tipo di dati

    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.
    Descrizione

    cyp3a4 or cyp2d6 inhibitors

    Tipo di dati

    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?
    Descrizione

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

    Tipo di dati

    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?
    Descrizione

    medical condition interaction with drug

    Tipo di dati

    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.
    Descrizione

    pregnancy, fathering

    Tipo di dati

    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 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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