ID

26517

Beschreibung

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders

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  1. 18.10.17 18.10.17 -
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18. Oktober 2017

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Screening Eligibility Checklist 7% CO2, GW597599, paroxetine and/or alprazolam in healthy volunteers 100690

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: Study Event
    1. Eligibility Criteria
Administrative Date
Beschreibung

Administrative Date

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
Beschreibung

Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C1512693
Is the subject healthy? Healthy subjects are defined as individuals who are free from clinically significant illness or disease (including dyspepsia and peptic ulcer) as determined by their medical history, physical examination, laboratory studies and other tests.
Beschreibung

Health status

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
Is the subject aged between 18 and 50 years included?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject eligible to enter and participate in the study if she is: a) of non-chilbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or b) of child-bearing potential, but has a negative urine pregnancy test at screen, and agrees to one of the following: I Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug; or, • Implants of levonorgestrel; or, Injectable progestogen; or, • Oral contraceptive (combined or progestogen only);or, • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1 % per year (not all IUDs meet this criterion); or, • Any other method with published data showing that the lowest expected failure rate for that method is less than 1 % per year.
Beschreibung

Sex | Childbearing-potential| Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0700589
Does the subject have a body mass index within the range 19-29kg/m2, with weight range of 55-95kg for males and 50-90 kg for females?
Beschreibung

BMI | Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Is the subject able to read, comprehend and write in the language of the Investigator?
Beschreibung

Language ability | Reading | Comprehension | Writing

Datentyp

boolean

Alias
UMLS CUI [1]
C1145677
UMLS CUI [2]
C0034754
UMLS CUI [3]
C0162340
UMLS CUI [4]
C2584304
Is the subject capable of giving informed consent and can comply with the study requirements and timetable?
Beschreibung

Informed consent | Patient compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
Has a signed and dated writte informed consent been obtained from the subject prior to study participation?
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Is the subject a non-smoker or smoker up to 15 cigarettes/day?
Beschreibung

Smoking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0678442
Is the subject defined as "prototypic panic attack responder" {after CO2 challenge= 11 VAS-A%.::. 26% and PSL 111-R.::. 4 (e.g. an increase of at least one point for at least 4 out of the 13 symptoms)} to a 7% CO2 inhalation performed within 1 and 12 months before the 1st study occasion.
Beschreibung

CO2 Inhalation response

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007012
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0521982
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?
Beschreibung

ECG

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
Beschreibung

Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0680251
Does the subject have personal or family history positive for cerebral aneurysm?
Beschreibung

Cerebral aneurysm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0917996
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0917996
UMLS CUI [2,2]
C0241889
Does the subject have history of psychiatric illness?
Beschreibung

Mental disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
Does the subject have clinically relevant abnormalities in the 12-lead ECG, prolonged QTc with >430msec in males and >450msec in females?
Beschreibung

Abnormal ECG | Prolonged QTc

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0151878
Is the subject currently taking regular medication or has taken any prescription medication within 28 days of first study start date?
Beschreibung

Pharmaceutical preparation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C1512806
Does the subject have a history of significant allergic, anaphylactic, hypersensitivity or idiosyncratic reaction to any drug that by the opinion of the investigator contraindicate their participation in the study?
Beschreibung

Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
Does the subject have history of an infection or symptoms (including common cold) within 2 weeks of first study drug dose?
Beschreibung

undefined item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C4288440
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C4288440
Does the subject have history or current evidence of drug abuse including a drinking habit of more than 28 units of alcohol per week for male and 21 units for female? (1 unit= 1/2 pint of beer/ 1 glass of wine/ 1 measure of spirit)
Beschreibung

Substance use disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Has the subject previously participated in a clinical study within 6 months of first study drug dose?
Beschreibung

Study participation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Is the subject concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device?
Beschreibung

Study participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C2346570
Has the subject donated 450ml or more of blood within 3 months of first study drug dose?
Beschreibung

Blood donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
Does the subject have any inability to participate in each of the 3 session of the study?
Beschreibung

Patient participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0679823
If female, is the subject pregnant or nursing, unwilling or unable to use ain appropriate method of contraception as outlined in Section 5.2.1 from at least 14 days prior to study medication administration until completion of follow-up procedures?
Beschreibung

Pregnancy | Breastfeeding | No Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C2919192
Is the subject sero-positive for hepatitis B and/or hepatitis C and/or HIV?
Beschreibung

Hepatitis B | Hepatitis C | HIV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0744862
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0744862
UMLS CUI [3,1]
C0019682
UMLS CUI [3,2]
C0019699
Is the subject responder to air-placebo inhalation performed wihtin 1 and 12 months before the 1st study occasion? (air-placebo challenge= fi VAS-A%~ 26% and PSL 111-R ~ 4 (e.g. an increase of at least one point for at least 4 out of the 13 symptoms).
Beschreibung

Air Placebo Inhalation responsiveness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0552602
UMLS CUI [1,2]
C0001861
UMLS CUI [1,3]
C1696465
UMLS CUI [1,4]
C0805586
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 inhibitor or inducer see Appendix 11: Inhibitors and inducers of Cytocrome P450 2D6 and 3A) 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?
Beschreibung

Prior medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
Has the subject consumed red wine, grapefruit or grapefruit juice and/or chininecontaining beverages within seven days before the first dosing? These foods are known inhibitors of the CYP3A4 or CYP206 enzyme system.
Beschreibung

CYP3A4 Inhibitor | CYP2D6 Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2,1]
C0057223
UMLS CUI [2,2]
C1999216
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: Study Event
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Date
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
C1516637 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
Health status
Item
Is the subject healthy? Healthy subjects are defined as individuals who are free from clinically significant illness or disease (including dyspepsia and peptic ulcer) as determined by their medical history, physical examination, laboratory studies and other tests.
boolean
C1708335 (UMLS CUI [1])
Age
Item
Is the subject aged between 18 and 50 years included?
boolean
C0001779 (UMLS CUI [1])
Sex | Childbearing-potential| Contraception
Item
If female, is the subject eligible to enter and participate in the study if she is: a) of non-chilbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or b) of child-bearing potential, but has a negative urine pregnancy test at screen, and agrees to one of the following: I Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug; or, • Implants of levonorgestrel; or, Injectable progestogen; or, • Oral contraceptive (combined or progestogen only);or, • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1 % per year (not all IUDs meet this criterion); or, • Any other method with published data showing that the lowest expected failure rate for that method is less than 1 % per year.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
BMI | Weight
Item
Does the subject have a body mass index within the range 19-29kg/m2, with weight range of 55-95kg for males and 50-90 kg for females?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Language ability | Reading | Comprehension | Writing
Item
Is the subject able to read, comprehend and write in the language of the Investigator?
boolean
C1145677 (UMLS CUI [1])
C0034754 (UMLS CUI [2])
C0162340 (UMLS CUI [3])
C2584304 (UMLS CUI [4])
Informed consent | Patient compliance
Item
Is the subject capable of giving informed consent and can comply with the study requirements and timetable?
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Informed consent
Item
Has a signed and dated writte informed consent been obtained from the subject prior to study participation?
boolean
C0021430 (UMLS CUI [1])
Smoking
Item
Is the subject a non-smoker or smoker up to 15 cigarettes/day?
boolean
C0543414 (UMLS CUI [1,1])
C0337672 (UMLS CUI [1,2])
C0543414 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0678442 (UMLS CUI [2,3])
CO2 Inhalation response
Item
Is the subject defined as "prototypic panic attack responder" {after CO2 challenge= 11 VAS-A%.::. 26% and PSL 111-R.::. 4 (e.g. an increase of at least one point for at least 4 out of the 13 symptoms)} to a 7% CO2 inhalation performed within 1 and 12 months before the 1st study occasion.
boolean
C0007012 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
ECG
Item
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
C0522054 (UMLS CUI [1])
Item Group
Does the subject meet the following eligibility criteria? Answer the following questions by marking the appropriate box.
C1516637 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Cerebral aneurysm
Item
Does the subject have personal or family history positive for cerebral aneurysm?
boolean
C0917996 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0917996 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Mental disorder
Item
Does the subject have history of psychiatric illness?
boolean
C0004936 (UMLS CUI [1])
Abnormal ECG | Prolonged QTc
Item
Does the subject have clinically relevant abnormalities in the 12-lead ECG, prolonged QTc with >430msec in males and >450msec in females?
boolean
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0151878 (UMLS CUI [2])
Pharmaceutical preparation
Item
Is the subject currently taking regular medication or has taken any prescription medication within 28 days of first study start date?
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
Hypersensitivity
Item
Does the subject have a history of significant allergic, anaphylactic, hypersensitivity or idiosyncratic reaction to any drug that by the opinion of the investigator contraindicate their participation in the study?
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
undefined item
Item
Does the subject have history of an infection or symptoms (including common cold) within 2 weeks of first study drug dose?
boolean
C3714514 (UMLS CUI [1,1])
C4288440 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C4288440 (UMLS CUI [2,2])
Substance use disorder
Item
Does the subject have history or current evidence of drug abuse including a drinking habit of more than 28 units of alcohol per week for male and 21 units for female? (1 unit= 1/2 pint of beer/ 1 glass of wine/ 1 measure of spirit)
boolean
C0038586 (UMLS CUI [1])
Study participation
Item
Has the subject previously participated in a clinical study within 6 months of first study drug dose?
boolean
C2348568 (UMLS CUI [1])
Study participation
Item
Is the subject concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device?
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
Blood donation
Item
Has the subject donated 450ml or more of blood within 3 months of first study drug dose?
boolean
C0005794 (UMLS CUI [1])
Patient participation
Item
Does the subject have any inability to participate in each of the 3 session of the study?
boolean
C1321605 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
Pregnancy | Breastfeeding | No Contraception
Item
If female, is the subject pregnant or nursing, unwilling or unable to use ain appropriate method of contraception as outlined in Section 5.2.1 from at least 14 days prior to study medication administration until completion of follow-up procedures?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C2919192 (UMLS CUI [3])
Hepatitis B | Hepatitis C | HIV
Item
Is the subject sero-positive for hepatitis B and/or hepatitis C and/or HIV?
boolean
C0019163 (UMLS CUI [1,1])
C0744862 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0744862 (UMLS CUI [2,2])
C0019682 (UMLS CUI [3,1])
C0019699 (UMLS CUI [3,2])
Air Placebo Inhalation responsiveness
Item
Is the subject responder to air-placebo inhalation performed wihtin 1 and 12 months before the 1st study occasion? (air-placebo challenge= fi VAS-A%~ 26% and PSL 111-R ~ 4 (e.g. an increase of at least one point for at least 4 out of the 13 symptoms).
boolean
C0552602 (UMLS CUI [1,1])
C0001861 (UMLS CUI [1,2])
C1696465 (UMLS CUI [1,3])
C0805586 (UMLS CUI [1,4])
Prior medication
Item
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 inhibitor or inducer see Appendix 11: Inhibitors and inducers of Cytocrome P450 2D6 and 3A) 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
C2826257 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
CYP3A4 Inhibitor | CYP2D6 Inhibitor
Item
Has the subject consumed red wine, grapefruit or grapefruit juice and/or chininecontaining beverages within seven days before the first dosing? These foods are known inhibitors of the CYP3A4 or CYP206 enzyme system.
boolean
C3830624 (UMLS CUI [1])
C0057223 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
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