ID

38074

Beschreibung

Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.

Stichworte

Versionen (1)
  1. 15.09.19 15.09.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. September 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988

Englisch

Eligibility Criteria

12 Formulare  
Administrative documentation
Beschreibung

Administrative documentation

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Criteria General
Beschreibung

Eligibility Criteria General

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Entry criteria fulfilled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C1516637
Eligibility Criteria - Inclusion Criteria
Beschreibung

Eligibility Criteria - Inclusion Criteria

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C1512693
Is the participant healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac monitoring?
Beschreibung

A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0521095
UMLS CUI [1,4]
C0031831
UMLS CUI [1,5]
C3826004
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0022885
UMLS CUI [5]
C0150496
Is the participant between 18 and 65 years of age, inclusive?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Is the body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 30?
Beschreibung

BMI = Weight in kg/(height in meters)^2

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Is the participant capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0009797
Eligibility Criteria - Exclusion Criteria
Beschreibung

Eligibility Criteria - Exclusion Criteria

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0680251
Does the participant have any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG?
Beschreibung

Clinically relevant abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0582103
UMLS CUI [2,1]
C0205210
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C0260877
UMLS CUI [3,1]
C0205210
UMLS CUI [3,2]
C2347946
UMLS CUI [3,3]
C1704258
UMLS CUI [3,4]
C0013798
Does the participant have a history of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses?
Beschreibung

Asthma, Anaphylaxis, anaphylactoid reactions or severe allergic responses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0002792
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0340865
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C1527304
UMLS CUI [4,3]
C0205082
Does the participant have a history of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of screening?
Beschreibung

one drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Does the subject have a positive pre-study urine drug/ urine alcohol screen?
Beschreibung

A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527048
UMLS CUI [1,2]
C0202274
UMLS CUI [1,3]
C1446409
UMLS CUI [2,1]
C1527048
UMLS CUI [2,2]
C0420032
UMLS CUI [2,3]
C1446409
Is the subject positive for HIV, Hepatitis B or Hepatitis C at screening?
Beschreibung

HIV, Hepatitis B or Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
Does the subject use prescription (including hormone replacement) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort)?
Beschreibung

This refers to 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. An exception is acetaminophen which is allowed at doses of < 2g/day.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0457083
UMLS CUI [1,2]
C0304227
UMLS CUI [2,1]
C0457083
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C1504473
UMLS CUI [5]
C0242295
Does the subject have exposure to more than four new chemical entities within 12 months prior to the first dosing day?
Beschreibung

Exposure to new chemical entities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0220806
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0205435
UMLS CUI [1,6]
C0439228
Has the subject participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication?
Beschreibung

Received clinical trial medication recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0205314
UMLS CUI [2,4]
C0220806
UMLS CUI [2,5]
C0332152
UMLS CUI [2,6]
C0332185
Did the subject consume grapefruit or grapefruit juice within 7 days prior to the first dose of study medication?
Beschreibung

Grapefruit juice consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0452456
UMLS CUI [2,2]
C0009830
UMLS CUI [2,3]
C0332185
Does the participant have a history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology?
Beschreibung

Cholecystectomy or biliary tract disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0008320
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0005424
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0023895
UMLS CUI [3,3]
C3163633
UMLS CUI [3,4]
C0023901
Is the subject pregnant or nursing?
Beschreibung

For female subjects, a positive serum β-hCG at screening or pre-dose of any session; or for female subjects of childbearing potential an unwillingness to agree to one of the methods of contraception listed in Protocol Section 7.3 from screening until the completion of follow-up procedures.

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Does the subject have a use of oral, injected and implanted hormonal methods of contraception (for female subjects)?
Beschreibung

Contraceptive method

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C2986768
UMLS CUI [2,2]
C0458083
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0458083
UMLS CUI [3,3]
C0700589
Would participation in the study result in donation of blood in excess of 500 mL within a 56 day period?
Beschreibung

Excess blood donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0553700
UMLS CUI [1,3]
C0442802
Does the participant have a history of sensitivity to any of the study medications (including ketoconazole for Part B only), or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation?
Beschreibung

Sensitivity to study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4284232
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0522473
UMLS CUI [1,5]
C2348568
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0184498
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0522473
UMLS CUI [2,5]
C2348568
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0205394
UMLS CUI [3,3]
C0522473
UMLS CUI [3,4]
C2348568
Does the participant have a history of sensitivity to heparin or heparin-induced thrombocytopenia (if heparin is to be used for flushing a cannula)?
Beschreibung

Heparin sensitivity or HIT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0272285
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019134
UMLS CUI [2,3]
C0020517
Does the subject have a use of other CYP 3A4 inhibitors or inducers within 14 days prior to dosing of study medication (Part B only)?
Beschreibung

CYP3A4 inducers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0457083
UMLS CUI [1,2]
C3830625
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0457083
UMLS CUI [2,2]
C3830624
UMLS CUI [2,3]
C0332185
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Ähnliche Modelle

Eligibility Criteria

12 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative documentation
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Criteria General
C1516637 (UMLS CUI-1)
Entry criteria fulfilled
Item
Did the subject meet all the entry criteria?
boolean
C1550543 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item Group
Eligibility Criteria - Inclusion Criteria
C1516637 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
Participant Healthy
Item
Is the participant healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac monitoring?
boolean
C0681850 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C3826004 (UMLS CUI [1,5])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C0150496 (UMLS CUI [5])
Age
Item
Is the participant between 18 and 65 years of age, inclusive?
boolean
C0001779 (UMLS CUI [1])
Weight and BMI
Item
Is the body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 30?
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
Is the participant capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
boolean
C2698977 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
Item Group
Eligibility Criteria - Exclusion Criteria
C1516637 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Clinically relevant abnormality
Item
Does the participant have any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG?
boolean
C0205210 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0582103 (UMLS CUI [1,4])
C0205210 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C0260877 (UMLS CUI [2,4])
C0205210 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C1704258 (UMLS CUI [3,3])
C0013798 (UMLS CUI [3,4])
Asthma, Anaphylaxis, anaphylactoid reactions or severe allergic responses
Item
Does the participant have a history of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses?
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0002792 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0340865 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C1527304 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Alcohol consumption
Item
Does the participant have a history of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men within 6 months of screening?
boolean
C0001948 (UMLS CUI [1])
Positive Drug or alcohol screen
Item
Does the subject have a positive pre-study urine drug/ urine alcohol screen?
boolean
C1527048 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C1527048 (UMLS CUI [2,1])
C0420032 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
HIV, Hepatitis B or Hepatitis C positive
Item
Is the subject positive for HIV, Hepatitis B or Hepatitis C at screening?
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Medication or supplement use
Item
Does the subject use prescription (including hormone replacement) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort)?
boolean
C0457083 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0457083 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
Exposure to new chemical entities
Item
Does the subject have exposure to more than four new chemical entities within 12 months prior to the first dosing day?
boolean
C0332157 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0439228 (UMLS CUI [1,6])
Received clinical trial medication recently
Item
Has the subject participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication?
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
C0220806 (UMLS CUI [2,4])
C0332152 (UMLS CUI [2,5])
C0332185 (UMLS CUI [2,6])
Grapefruit juice consumption
Item
Did the subject consume grapefruit or grapefruit juice within 7 days prior to the first dose of study medication?
boolean
C0995150 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0452456 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Cholecystectomy or biliary tract disease
Item
Does the participant have a history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology?
boolean
C0262926 (UMLS CUI [1,1])
C0008320 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0005424 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C3163633 (UMLS CUI [3,3])
C0023901 (UMLS CUI [3,4])
Pregnant or nursing
Item
Is the subject pregnant or nursing?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive method
Item
Does the subject have a use of oral, injected and implanted hormonal methods of contraception (for female subjects)?
boolean
C0442027 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C2986768 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0021102 (UMLS CUI [3,1])
C0458083 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Excess blood donation
Item
Would participation in the study result in donation of blood in excess of 500 mL within a 56 day period?
boolean
C2348568 (UMLS CUI [1,1])
C0553700 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
Sensitivity to study medication
Item
Does the participant have a history of sensitivity to any of the study medications (including ketoconazole for Part B only), or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation?
boolean
C0020517 (UMLS CUI [1,1])
C4284232 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0522473 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
C0020517 (UMLS CUI [2,1])
C0184498 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0522473 (UMLS CUI [2,4])
C2348568 (UMLS CUI [2,5])
C0020517 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0522473 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
Heparin sensitivity or HIT
Item
Does the participant have a history of sensitivity to heparin or heparin-induced thrombocytopenia (if heparin is to be used for flushing a cannula)?
boolean
C0262926 (UMLS CUI [1,1])
C0272285 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
CYP3A4 inducers
Item
Does the subject have a use of other CYP 3A4 inhibitors or inducers within 14 days prior to dosing of study medication (Part B only)?
boolean
C0457083 (UMLS CUI [1,1])
C3830625 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0457083 (UMLS CUI [2,1])
C3830624 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
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