ID

34609

Beschreibung

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Stichworte

Versionen (1)
  1. 19.01.19 19.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. Januar 2019

DOI

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Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Englisch

Eligibility Form

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Form
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Beschreibung

Eligibility Question

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

Eligibility Determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
Beschreibung

Health Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0018759
Male and female subjects between the ages of 18 to 64, inclusive.
Beschreibung

Gender, Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories: • non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females defined as being amenorrheic for greater than 1 year and having estradiol and FSH levels consistent with menopause • child-bearing potential with negative βhCG test and agrees to comply with recognized non- hormonal contraceptive methods from screening or at least two weeks prior to first dose (whichever is earlier) until the follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, two forms of barrier contraception (e.g. condom with spermicide, or diaphragm with spermicide), or intrauterine device (IUD).
Beschreibung

Pregnancy, Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Body Weight > 50 kg for males and > 45 kg for females.
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Body Mass Index (BMI) in the range of 19 - 30 kg/m2 BMI = weight [kg]/(height [m]) 2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
Beschreibung

Comprehension, Study Protocol; Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0525058
Capable of giving written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, 12-lead electrocardiogram (ECG).
Beschreibung

Abnormality, Clinically Significant Indicator

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
History of Gilbert's syndrome.
Beschreibung

Gilbert Disease (disorder), Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017551
UMLS CUI [1,2]
C0262926
Any previous history of deep vein thrombosis or any other thromboembolic event.
Beschreibung

Deep Vein Thrombosis, Thromboembolism, Medical History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0040038
UMLS CUI [1,3]
C0262926
History of sensitivity to heparin, or heparin-induced thrombocytopenia.
Beschreibung

Heparin, Hypersensitivity; Heparin-induced thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0272285
History of sensitivity to any of the study medications, or components thereof.
Beschreibung

Experimental Drug, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
History of myocardial infarction, stroke, or sudden death in a first degree family member at age of < 60 years.
Beschreibung

Myocardial Infarction, Cerebrovascular Event, Sudden Death, Family History

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0011071
UMLS CUI [1,4]
C0241889
History of thrombocytopenia or bleeding due to abnormal platelet number or function.
Beschreibung

Thrombocytopenia; Hemorrhage, Platelet count abnormal; Hemorrhage, Platelet function, Abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0580317
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C1254881
UMLS CUI [3,3]
C0205161
History of platelet clumping that prevents reliable measurement of platelet counts.
Beschreibung

Platelet Clumps

Datentyp

boolean

Alias
UMLS CUI [1]
C0427569
History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
Beschreibung

Atrial Fibrillation, Mitral Valve Prolapse Syndrome, Heart Murmur, Arterial Bruit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0026267
UMLS CUI [1,3]
C0018808
UMLS CUI [1,4]
C0232112
Prolonged QTc interval (Bazett's) at screening (for females > 450 msec and for males > 430 msec).
Beschreibung

QTcB - Bazett's Correction Formula

Datentyp

boolean

Alias
UMLS CUI [1]
C1882512
Elevated blood pressure at screening (systolic >140 mm Hg, diastolic >85 mm Hg).
Beschreibung

Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
Clinically significant liver function tests (LFTs) outside the reference range at screening.
Beschreibung

Liver Function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
Beschreibung

Blood Coagulation Factor, Abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005789
UMLS CUI [1,2]
C1704258
A hemoglobin, hematocrit, red blood count and/or reticulocyte count outside the normal reference range, and/or clinically significant abnormalities of the remainder of the analytes of the CBC.
Beschreibung

Hemoglobin measurement, Hematocrit level, Red Blood Cell Count measurement, Reticulocyte count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0518014
UMLS CUI [1,3]
C0014772
UMLS CUI [1,4]
C0206161
Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as described in Protocol Section 5.2.1 Inclusion Criteria.
Beschreibung

Childbearing Potential, Contraceptive method, Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
For female subjects, a positive βhCG at screening or pre-dose in any period.
Beschreibung

Beta HCG positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0813152
For female subjects, currently receiving hormone replacement therapy (HRT).
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
Unwillingness of male subjects to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 28 days after the last dose of study medication.
Beschreibung

Contraceptive methods, Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
Beschreibung

HIV Infections , Hepatitis B, Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
Positive urine drug screen including alcohol at screening or pre-dose.
Beschreibung

Urine drug screening

Datentyp

boolean

Alias
UMLS CUI [1]
C0202274
History of alcohol/drug abuse or dependence within 12 months of the study.
Beschreibung

Substance Use Disoders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/ week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
Beschreibung

Alcohol Consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Urinary cotinine levels indicative of smoking at screening or pre-dose. History of regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Beschreibung

Cotinine measurement, Tobacco Use, Nicotine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0543414
UMLS CUI [1,3]
C0028040
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Beschreibung

Experimental Drug, Exposure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332157
Use of prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. John's Wort within 7 days prior to the first dose of study medication. By exception, acetaminophen at doses of < 2g/day, stable thyroid replacement therapy will be allowed.
Beschreibung

Pharmaceutic Preparations, Vitamins, Herbal Supplements, Dietary Supplements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0042890
UMLS CUI [1,3]
C1504473
UMLS CUI [1,4]
C0242295
Consumption of liquid antacids (e.g. Maalox, Mylanta, Amphogel, Milk of Magnesia) or chewable antacids (e.g. TUMSTM) within 48 hours of the first dose of study medication until the final pharmacokinetic sample of the study has been taken.
Beschreibung

Antacids

Datentyp

boolean

Alias
UMLS CUI [1]
C0003138
Subjects who have donated plasma within 7 days prior to the screening visit or more than 500 mL of blood within 56 days prior to the start of the study.
Beschreibung

Blood Donation, Plasma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0032105
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Ähnliche Modelle

Eligibility Form

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Health Status
Item
Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
boolean
C0018759 (UMLS CUI [1])
Gender, Age
Item
Male and female subjects between the ages of 18 to 64, inclusive.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Pregnancy, Breast Feeding
Item
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories: • non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy, or post-menopausal females defined as being amenorrheic for greater than 1 year and having estradiol and FSH levels consistent with menopause • child-bearing potential with negative βhCG test and agrees to comply with recognized non- hormonal contraceptive methods from screening or at least two weeks prior to first dose (whichever is earlier) until the follow-up visit. Recognized non-hormonal contraceptive methods include: complete abstinence from intercourse, two forms of barrier contraception (e.g. condom with spermicide, or diaphragm with spermicide), or intrauterine device (IUD).
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Body Weight
Item
Body Weight > 50 kg for males and > 45 kg for females.
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
Body Mass Index (BMI) in the range of 19 - 30 kg/m2 BMI = weight [kg]/(height [m]) 2
boolean
C1305855 (UMLS CUI [1])
Comprehension, Study Protocol; Protocol Compliance
Item
Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Informed Consent
Item
Capable of giving written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Abnormality, Clinically Significant Indicator
Item
Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, 12-lead electrocardiogram (ECG).
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Gilbert Disease (disorder), Medical History
Item
History of Gilbert's syndrome.
boolean
C0017551 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Deep Vein Thrombosis, Thromboembolism, Medical History
Item
Any previous history of deep vein thrombosis or any other thromboembolic event.
boolean
C0149871 (UMLS CUI [1,1])
C0040038 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Heparin, Hypersensitivity; Heparin-induced thrombocytopenia
Item
History of sensitivity to heparin, or heparin-induced thrombocytopenia.
boolean
C0019134 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
Experimental Drug, Hypersensitivity
Item
History of sensitivity to any of the study medications, or components thereof.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Myocardial Infarction, Cerebrovascular Event, Sudden Death, Family History
Item
History of myocardial infarction, stroke, or sudden death in a first degree family member at age of < 60 years.
boolean
C0027051 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0011071 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
Thrombocytopenia; Hemorrhage, Platelet count abnormal; Hemorrhage, Platelet function, Abnormal
Item
History of thrombocytopenia or bleeding due to abnormal platelet number or function.
boolean
C0040034 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C0580317 (UMLS CUI [2,2])
C0019080 (UMLS CUI [3,1])
C1254881 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
Platelet Clumps
Item
History of platelet clumping that prevents reliable measurement of platelet counts.
boolean
C0427569 (UMLS CUI [1])
Atrial Fibrillation, Mitral Valve Prolapse Syndrome, Heart Murmur, Arterial Bruit
Item
History of atrial fibrillation, mitral valve prolapse, significant heart murmur or vascular bruit.
boolean
C0004238 (UMLS CUI [1,1])
C0026267 (UMLS CUI [1,2])
C0018808 (UMLS CUI [1,3])
C0232112 (UMLS CUI [1,4])
QTcB - Bazett's Correction Formula
Item
Prolonged QTc interval (Bazett's) at screening (for females > 450 msec and for males > 430 msec).
boolean
C1882512 (UMLS CUI [1])
Blood Pressure
Item
Elevated blood pressure at screening (systolic >140 mm Hg, diastolic >85 mm Hg).
boolean
C0005823 (UMLS CUI [1])
Liver Function
Item
Clinically significant liver function tests (LFTs) outside the reference range at screening.
boolean
C0232741 (UMLS CUI [1])
Blood Coagulation Factor, Abnormality
Item
Clotting factor abnormalities associated with hypercoagulability, specifically Factor V Leiden, Protein C or Protein S deficiency or antithrombin III deficiency.
boolean
C0005789 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Hemoglobin measurement, Hematocrit level, Red Blood Cell Count measurement, Reticulocyte count
Item
A hemoglobin, hematocrit, red blood count and/or reticulocyte count outside the normal reference range, and/or clinically significant abnormalities of the remainder of the analytes of the CBC.
boolean
C0518015 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,3])
C0206161 (UMLS CUI [1,4])
Childbearing Potential, Contraceptive method, Unwilling
Item
Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as described in Protocol Section 5.2.1 Inclusion Criteria.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Beta HCG positive
Item
For female subjects, a positive βhCG at screening or pre-dose in any period.
boolean
C0813152 (UMLS CUI [1])
Hormone replacement therapy
Item
For female subjects, currently receiving hormone replacement therapy (HRT).
boolean
C0282402 (UMLS CUI [1])
Contraceptive methods, Unwilling
Item
Unwillingness of male subjects to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 28 days after the last dose of study medication.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
HIV Infections , Hepatitis B, Hepatitis C
Item
Positive for HIV, hepatitis B virus or hepatitis C virus assays at screening.
boolean
C0019693 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Urine drug screening
Item
Positive urine drug screen including alcohol at screening or pre-dose.
boolean
C0202274 (UMLS CUI [1])
Substance Use Disoders
Item
History of alcohol/drug abuse or dependence within 12 months of the study.
boolean
C0038586 (UMLS CUI [1])
Alcohol Consumption
Item
History of alcohol consumption in the past six months exceeding 7 units/week for women and 14 units/ week for men (where 1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor).
boolean
C0001948 (UMLS CUI [1])
Cotinine measurement, Tobacco Use, Nicotine
Item
Urinary cotinine levels indicative of smoking at screening or pre-dose. History of regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
boolean
C0202363 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
Investigational New Drugs
Item
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Experimental Drug, Exposure
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C0304229 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Pharmaceutic Preparations, Vitamins, Herbal Supplements, Dietary Supplements
Item
Use of prescription or non-prescription drugs (including aspirin and NSAIDs), vitamins, herbal and dietary supplements, or any herbal remedies containing St. John's Wort within 7 days prior to the first dose of study medication. By exception, acetaminophen at doses of < 2g/day, stable thyroid replacement therapy will be allowed.
boolean
C0013227 (UMLS CUI [1,1])
C0042890 (UMLS CUI [1,2])
C1504473 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
Antacids
Item
Consumption of liquid antacids (e.g. Maalox, Mylanta, Amphogel, Milk of Magnesia) or chewable antacids (e.g. TUMSTM) within 48 hours of the first dose of study medication until the final pharmacokinetic sample of the study has been taken.
boolean
C0003138 (UMLS CUI [1])
Blood Donation, Plasma
Item
Subjects who have donated plasma within 7 days prior to the screening visit or more than 500 mL of blood within 56 days prior to the start of the study.
boolean
C0005794 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
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