ID

30542

Beschreibung

Study part: Eligibility Questions (Elig). A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

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  1. 13.06.18 13.06.18 -
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GlaxoSmithKline

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13. Juni 2018

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Eligibility Questions (Elig) Pazopanib Macular Degeneration MD1103367

Englisch

Eligibility Questions (Elig)

1 Formulare  
ELIGIBILITY QUESTION
Beschreibung

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

Clinical Trial Eligibility Criteria

Datentyp

text

Alias
UMLS CUI [1]
C1516637
Do not admit the subject into this study if any Inclusion/ Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemptions below
Beschreibung

eligibility determination exemptions

Datentyp

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C2348482
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Healthy male or female, 55 years of age or older
Beschreibung

I01

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
2. A female is eligible to participate in this study if she is of non-childbearing potential (see protocol for details).
Beschreibung

I02

Datentyp

boolean

Alias
UMLS CUI [1]
C1960468
3. Body weight 50 kg for men and 45 kg for women.
Beschreibung

I03

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
4. Body Mass lndex (Quetelet index) in the range of 19-30. Body Mass Index = weight [kgj/height [mJ)2.
Beschreibung

I04

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
5. Capable of giving written informed consent, which includes compliance with the protocol requirements and restrictions.
Beschreibung

I05

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0525058
6. Best-corrected visual acuity better than 20/80 in at least one eye.
Beschreibung

I06

Datentyp

boolean

Alias
UMLS CUI [1]
C1690532
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. A subject will not be eligible for inclusion in this study if any of the following criteria apply: Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or 12-lead ECG.
Beschreibung

E01

Datentyp

boolean

Alias
UMLS CUI [1]
C0459424
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0430456
2. History of clinically relevant impaired endocrine, thyroid, hepatic, respiratory or renal function, hypertension, diabetes mellitus, coronary heart disease, or psychotic mental illness.
Beschreibung

E02

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0521425
UMLS CUI [1,3]
C0040130
UMLS CUI [1,4]
C0205054
3. History of any clotting disorder, including predisposition to hypercoagulation or any previous thromboembolic event.
Beschreibung

E03

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0398623
UMLS CUI [1,3]
C0040038
4. Abnormal values for activated protein C resistance, factor V Leiden mutation, protein C, protein S, prothrombin G20210A mutation, homocysteine, or anti-thrombin.
Beschreibung

E04

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0600433
UMLS CUI [1,3]
C0584960
UMLS CUI [1,4]
C0033621
5. History of sensitivity to any of the study medications or components thereof.
Beschreibung

E05

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
6. Blood pressure and heart rate in seated position at the screening examination outside the ranges of 90- 140 mmHg systolic/ 50-90 mmHg diastolic and 45-100 beat /min, respectively.
Beschreibung

E06

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C0018810
7. Any prior intraocular surgery, excluding cataract surgery.
Beschreibung

E07

Datentyp

boolean

Alias
UMLS CUI [1]
C0038901
UMLS CUI [2]
C2939459
8. Any prior eye surgery three month prior to first dose of study medication.
Beschreibung

E08

Datentyp

boolean

Alias
UMLS CUI [1]
C0038901
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0304229
9. Use of prescription or non-prescription drugs (including aspirin or SAIDs), with the exception of acetaminophen ( 2 grams/day), within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Beschreibung

E09

Datentyp

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0080151
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
10. Use of vitamins or dietary/herbal supplements, see protocol for details, within 7 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Beschreibung

E10

Datentyp

boolean

Alias
UMLS CUI [1]
C0242295
11 . Consumption of grapefruit or grapefruit juice within 7 days prior to administration of study medication.
Beschreibung

E11

Datentyp

boolean

Alias
UMLS CUI [1]
C0995150
UMLS CUI [2]
C0452456
12. Participation in a clinical study of an investigational or non-investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Beschreibung

E12

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
13. History of drug or alcohol abuse or positive urine drug screen (including alcohol).
Beschreibung

E13

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0042014
14. History of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Beschreibung

E14

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0038586
15. History or regular use of tobacco- or nicotine-containing products within six months of the study or positive urine cotinine screen, or > 10 pack-year history of smoking.
Beschreibung

E15

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0376384
16. Positive screen for hepatitis B, hepatitis C, HIV-1 or HIV2.
Beschreibung

E16

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1446409
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
UMLS CUI [1,4]
C0019704
UMLS CUI [1,5]
C0019707
17. Donation of blood in excess of 500 mL within 56 days prior to dosing.
Beschreibung

E17

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
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Ähnliche Modelle

Eligibility Questions (Elig)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ELIGIBILITY QUESTION
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
undefined item
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
eligibility determination exemptions
Item
Do not admit the subject into this study if any Inclusion/ Exclusion criteria is checked unless an exception has been granted by the GSK Medical Monitor and subject is continuing in the study. Please clarify the exemptions below
text
C0013893 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
gender; age
Item
1. Healthy male or female, 55 years of age or older
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Female of child bearing age
Item
2. A female is eligible to participate in this study if she is of non-childbearing potential (see protocol for details).
boolean
C1960468 (UMLS CUI [1])
Body weight
Item
3. Body weight 50 kg for men and 45 kg for women.
boolean
C0005910 (UMLS CUI [1])
Body Mass lndex
Item
4. Body Mass lndex (Quetelet index) in the range of 19-30. Body Mass Index = weight [kgj/height [mJ)2.
boolean
C1305855 (UMLS CUI [1])
informed consent; Protocol Compliance
Item
5. Capable of giving written informed consent, which includes compliance with the protocol requirements and restrictions.
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Best-corrected visual acuity
Item
6. Best-corrected visual acuity better than 20/80 in at least one eye.
boolean
C1690532 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
abnormal result; medical history; physical examination; 12- Lead ECG
Item
1. A subject will not be eligible for inclusion in this study if any of the following criteria apply: Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or 12-lead ECG.
boolean
C0459424 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
Laboratory test result abnormal endocrine thyroid
Item
2. History of clinically relevant impaired endocrine, thyroid, hepatic, respiratory or renal function, hypertension, diabetes mellitus, coronary heart disease, or psychotic mental illness.
boolean
C0438215 (UMLS CUI [1,1])
C0521425 (UMLS CUI [1,2])
C0040130 (UMLS CUI [1,3])
C0205054 (UMLS CUI [1,4])
clotting disorder; hypercoagulation; Thromboembolism
Item
3. History of any clotting disorder, including predisposition to hypercoagulation or any previous thromboembolic event.
boolean
C0005779 (UMLS CUI [1,1])
C0398623 (UMLS CUI [1,2])
C0040038 (UMLS CUI [1,3])
abnormal result activated protein C resistance factor V Leiden mutation protein C
Item
4. Abnormal values for activated protein C resistance, factor V Leiden mutation, protein C, protein S, prothrombin G20210A mutation, homocysteine, or anti-thrombin.
boolean
C0438215 (UMLS CUI [1,1])
C0600433 (UMLS CUI [1,2])
C0584960 (UMLS CUI [1,3])
C0033621 (UMLS CUI [1,4])
Hypersensitivity Experimental drug
Item
5. History of sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Blood pressure; Heart rate
Item
6. Blood pressure and heart rate in seated position at the screening examination outside the ranges of 90- 140 mmHg systolic/ 50-90 mmHg diastolic and 45-100 beat /min, respectively.
boolean
C0005823 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
intraocular surgery; cataract surgery
Item
7. Any prior intraocular surgery, excluding cataract surgery.
boolean
C0038901 (UMLS CUI [1])
C2939459 (UMLS CUI [2])
eye surgery; dosage study medication
Item
8. Any prior eye surgery three month prior to first dose of study medication.
boolean
C0038901 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
aspirin; SAIDs; exception acetaminophen
Item
9. Use of prescription or non-prescription drugs (including aspirin or SAIDs), with the exception of acetaminophen ( 2 grams/day), within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
boolean
C0004057 (UMLS CUI [1])
C0080151 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Dietary Supplements
Item
10. Use of vitamins or dietary/herbal supplements, see protocol for details, within 7 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0242295 (UMLS CUI [1])
grapefruit; grapefruit juice
Item
11 . Consumption of grapefruit or grapefruit juice within 7 days prior to administration of study medication.
boolean
C0995150 (UMLS CUI [1])
C0452456 (UMLS CUI [2])
Study Subject Participation Status
Item
12. Participation in a clinical study of an investigational or non-investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C2348568 (UMLS CUI [1])
Substance Use Disorders; urine test
Item
13. History of drug or alcohol abuse or positive urine drug screen (including alcohol).
boolean
C0038586 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
medical history; Substance Use Disorders
Item
14. History of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0262926 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Tobacco use; nicotine use
Item
15. History or regular use of tobacco- or nicotine-containing products within six months of the study or positive urine cotinine screen, or > 10 pack-year history of smoking.
boolean
C0543414 (UMLS CUI [1])
C0376384 (UMLS CUI [2])
Positive hepatitis B hepatitis C HIV-1
Item
16. Positive screen for hepatitis B, hepatitis C, HIV-1 or HIV2.
boolean
C1446409 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0019704 (UMLS CUI [1,4])
C0019707 (UMLS CUI [1,5])
blood donation
Item
17. Donation of blood in excess of 500 mL within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1])
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