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

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StudyEvent: ODM
1. GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Eligibility Checklist

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Inclusion Criteria

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])

pregnancy test

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])

Exclusion Criteria

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