ID

31914

Beschreibung

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 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: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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  1. 08.10.18 08.10.18 -
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GlaxoSmithKline

Hochgeladen am

8. Oktober 2018

DOI

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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility
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
The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by a responsible physician, with no abnormality identified on the medical or laboratory evaluation, including 12-lead ECG.
Beschreibung

Healthy

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
The subject is male or female. Women must be of non-childbearing potential (i.e., physiologically incapable of becoming pregnant as defined in Section 7.4.1 of the protocol). Post-menopausal status must be confirmed at Screening by FSH and estradiol testing.
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Subject is 18 - 60 years of age inclusive at the time of signing the informed consent.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Subject’s BMI (body mass index) is within the range 19.9-35 kg/m2, inclusive.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
A signed and dated written informed consent is obtained prior to admission to the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
The subject is able to understand and comply with protocol requirements, instructions and protocol- stated restrictions.
Beschreibung

Comprehension; Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0162340
UMLS CUI [2]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
Beschreibung

Medically unfit; Clinical research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0008972
Subject has a positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV testing result.
Beschreibung

Hepatitis B surface antigen positive; Hepatitis C positive; HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
Subject has fasting plasma glucose greater than 126mg/dL.
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
Subject has history of or an abnormal thyroid function test assessed by TSH at Screening.
Beschreibung

Thyroid dysfunction, poorly controlled; Thyroid function tests abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348024
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0476414
Subject has aspartate aminotransferase (), alanine aminotransferase (ALT), direct (conjugated) bilirubin, and/or alkaline phosphatase values above 1.5 times the upper limit of normal detected at Screening.
Beschreibung

Aspartate aminotransferase measurement; Alanine aminotransferase measurement; Bilirubin, direct measurement; Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201916
UMLS CUI [4]
C0201850
Subject has history of cholelithiasis or obstructive or inflammatory gall bladder disease within the 3 months prior to Screening.
Beschreibung

Cholelithiasis; Gall bladder diseases, inflammatory

Datentyp

boolean

Alias
UMLS CUI [1]
C0008350
UMLS CUI [2,1]
C0016977
UMLS CUI [2,2]
C0333348
Subject has history of gastrointestinal disease that could affect fat or bile acid absorption, including inflammatory bowel disease, chronic diarrhea, Crohn’s or malabsorption syndromes within the past year.
Beschreibung

Gastrointestinal Diseases, Affecting, Gastrointestinal Absorption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3714657
Subject has history of gastrointestinal surgical intervention for obesity.
Beschreibung

Bariatric Surgery; Obesity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C0028754
Subject has history of chronic or acute pancreatitis.
Beschreibung

Acute pancreatitis; Pancreatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0001339
UMLS CUI [2]
C0149521
Subject has LDL >160 mg/dL, triglycerides >240 mg/dL.
Beschreibung

Low density lipoprotein cholesterol measurement; Triglycerides measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202117
UMLS CUI [2]
C0202236
Subject has history of clinically significant cardiovascular disease including: • Active, unstable coronary heart disease (CHD) within the past 6 months • Documented myocardial infarction within a year prior to Screening • Any cardiac surgery including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery within a year prior to Screening • Unstable angina • Clinically significant arrhythmia or valvular heart disease within the past year • Congestive heart failure (CHF) with New York Heart Association (NYHA) Class I-IV symptoms • Untreated hypertension, with systolic pressure greater than 160 and/or diastolic pressure greater than 95. • ECG Exclusion criteria: Males: Heart rate <40 and >100bpm; PR interval <120 and >210msec; QRS duration <70 and >120msec; QTc interval (Bazett) >440msec Females: Heart rate <40 and >100bpm; PR interval <120 and >210msec; QRS duration <70 and >120msec; QTc interval (Bazett) >460msec
Beschreibung

Cardiovascular diseases; Clinical significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
Subject has significant renal disease as manifested by one or more of the following: • Creatinine clearance <60 mL/min (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation): • A validated web-based calculator for GFR is found at http://nephron.com/cgi-bin/ MDRDSIdefault.cgi • To calculate estimated GFR (mL/min/1.73m2) manually: =186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American) =exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American)) • Urine protein/creatinine (mg/mg) ratio >2.5; or urine albumin concentration >300 􏰁g/mg of creatinine. • Known loss of a kidney either by surgical ablation, injury, or disease.
Beschreibung

Kidney diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
Subject has history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation, including allergy to heparin, if heparin will be used to maintain catheter patency.
Beschreibung

Drug Allergy, Medical contraindication, Study Subject Participation Status; Hypersensitivity,Medical contraindication, Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C2348568
Subject has history of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
Beschreibung

Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
Subject is unwilling to abstain from alcohol for 24 hours prior to the start of dosing until discharge from the clinic.
Beschreibung

Alcohol abstinence, unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0558080
Subject has smoked or used tobacco or nicotine-containing products within the previous 6 months.
Beschreibung

Smoking History; Tobacco use; Nicotine

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C0543414
UMLS CUI [3]
C0028040
Subject has had treatment with a new molecular entity (investigational drug) or has participated in any other clinical trial during the previous 30 days, or five half-lives, whichever is longer.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Subject is unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
Beschreibung

Drug Abstinence, Unwilling; Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237443
UMLS CUI [1,2]
C0558080
UMLS CUI [2]
C1321605
Subject has used St. John’s Wort within 14 days prior to dosing and through Day 42 of the study.
Beschreibung

Hypericum perforatum

Datentyp

boolean

Alias
UMLS CUI [1]
C0936242
Subject is unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until discharge from clinic.
Beschreibung

Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006644
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0043314
UMLS CUI [2,2]
C3843422
UMLS CUI [2,3]
C0558080
Subject has a positive pre-study drug/urine screen.
Beschreibung

Urine drug screen positive; Drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0743295
Subject has a pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products.
Beschreibung

Urine cotinine test

Datentyp

boolean

Alias
UMLS CUI [1]
C1697737
Subject has used prescription or non-prescription drugs, vitamins, dietary/herbal supplements or hormone replacement therapy within 2 weeks prior to the first dose of study medication with the exception of acetaminophen, which may be used at label dosages as needed throughout the trial.
Beschreibung

Drug usage; Vitamin supplementation; Dietary Supplements; Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0242510
UMLS CUI [2]
C0302837
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0282402
Has previously received exenatide or any other GLP-1 mimetic in a clinical trial, or has a positive antibody titer at Screening.
Beschreibung

exenatide; GLP-1 Mimetics; Antibody screen, Titer

Datentyp

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C3273809
UMLS CUI [3,1]
C0368676
UMLS CUI [3,2]
C0475208
The subject has donated 500 or more mL of blood within 56 days prior to dosing or has intention of donating blood in the month following the study.
Beschreibung

Blood donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
Beschreibung

Family member, Research Personnel; Staff Member

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C1552089
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
Healthy
Item
The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by a responsible physician, with no abnormality identified on the medical or laboratory evaluation, including 12-lead ECG.
boolean
C3898900 (UMLS CUI [1])
Gender
Item
The subject is male or female. Women must be of non-childbearing potential (i.e., physiologically incapable of becoming pregnant as defined in Section 7.4.1 of the protocol). Post-menopausal status must be confirmed at Screening by FSH and estradiol testing.
boolean
C0079399 (UMLS CUI [1])
Age
Item
Subject is 18 - 60 years of age inclusive at the time of signing the informed consent.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
Subject’s BMI (body mass index) is within the range 19.9-35 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
A signed and dated written informed consent is obtained prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Comprehension; Compliance behavior
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol- stated restrictions.
boolean
C0162340 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Medically unfit; Clinical research
Item
As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
boolean
C3841806 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Hepatitis B surface antigen positive; Hepatitis C positive; HIV Seropositivity
Item
Subject has a positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV testing result.
boolean
C0149709 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Plasma fasting glucose measurement
Item
Subject has fasting plasma glucose greater than 126mg/dL.
boolean
C0583513 (UMLS CUI [1])
Thyroid dysfunction, poorly controlled; Thyroid function tests abnormal
Item
Subject has history of or an abnormal thyroid function test assessed by TSH at Screening.
boolean
C0348024 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0476414 (UMLS CUI [2])
Aspartate aminotransferase measurement; Alanine aminotransferase measurement; Bilirubin, direct measurement; Alkaline phosphatase measurement
Item
Subject has aspartate aminotransferase (), alanine aminotransferase (ALT), direct (conjugated) bilirubin, and/or alkaline phosphatase values above 1.5 times the upper limit of normal detected at Screening.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Cholelithiasis; Gall bladder diseases, inflammatory
Item
Subject has history of cholelithiasis or obstructive or inflammatory gall bladder disease within the 3 months prior to Screening.
boolean
C0008350 (UMLS CUI [1])
C0016977 (UMLS CUI [2,1])
C0333348 (UMLS CUI [2,2])
Gastrointestinal Diseases, Affecting, Gastrointestinal Absorption
Item
Subject has history of gastrointestinal disease that could affect fat or bile acid absorption, including inflammatory bowel disease, chronic diarrhea, Crohn’s or malabsorption syndromes within the past year.
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3714657 (UMLS CUI [1,3])
Bariatric Surgery; Obesity
Item
Subject has history of gastrointestinal surgical intervention for obesity.
boolean
C1456587 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
Acute pancreatitis; Pancreatitis, Chronic
Item
Subject has history of chronic or acute pancreatitis.
boolean
C0001339 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Low density lipoprotein cholesterol measurement; Triglycerides measurement
Item
Subject has LDL >160 mg/dL, triglycerides >240 mg/dL.
boolean
C0202117 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Cardiovascular diseases; Clinical significance
Item
Subject has history of clinically significant cardiovascular disease including: • Active, unstable coronary heart disease (CHD) within the past 6 months • Documented myocardial infarction within a year prior to Screening • Any cardiac surgery including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery within a year prior to Screening • Unstable angina • Clinically significant arrhythmia or valvular heart disease within the past year • Congestive heart failure (CHF) with New York Heart Association (NYHA) Class I-IV symptoms • Untreated hypertension, with systolic pressure greater than 160 and/or diastolic pressure greater than 95. • ECG Exclusion criteria: Males: Heart rate <40 and >100bpm; PR interval <120 and >210msec; QRS duration <70 and >120msec; QTc interval (Bazett) >440msec Females: Heart rate <40 and >100bpm; PR interval <120 and >210msec; QRS duration <70 and >120msec; QTc interval (Bazett) >460msec
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Kidney diseases
Item
Subject has significant renal disease as manifested by one or more of the following: • Creatinine clearance <60 mL/min (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation): • A validated web-based calculator for GFR is found at http://nephron.com/cgi-bin/ MDRDSIdefault.cgi • To calculate estimated GFR (mL/min/1.73m2) manually: =186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American) =exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American)) • Urine protein/creatinine (mg/mg) ratio >2.5; or urine albumin concentration >300 􏰁g/mg of creatinine. • Known loss of a kidney either by surgical ablation, injury, or disease.
boolean
C0022658 (UMLS CUI [1])
Drug Allergy, Medical contraindication, Study Subject Participation Status; Hypersensitivity,Medical contraindication, Subject Participation Status
Item
Subject has history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation, including allergy to heparin, if heparin will be used to maintain catheter patency.
boolean
C0013182 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Alcohol abuse
Item
Subject has history of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
boolean
C0085762 (UMLS CUI [1])
Alcohol abstinence, unwilling
Item
Subject is unwilling to abstain from alcohol for 24 hours prior to the start of dosing until discharge from the clinic.
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Smoking History; Tobacco use; Nicotine
Item
Subject has smoked or used tobacco or nicotine-containing products within the previous 6 months.
boolean
C1519384 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C0028040 (UMLS CUI [3])
Study Subject Participation Status
Item
Subject has had treatment with a new molecular entity (investigational drug) or has participated in any other clinical trial during the previous 30 days, or five half-lives, whichever is longer.
boolean
C2348568 (UMLS CUI [1])
Drug Abstinence, Unwilling; Compliance behavior
Item
Subject is unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
boolean
C0237443 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
Hypericum perforatum
Item
Subject has used St. John’s Wort within 14 days prior to dosing and through Day 42 of the study.
boolean
C0936242 (UMLS CUI [1])
Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling
Item
Subject is unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until discharge from clinic.
boolean
C0006644 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0043314 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Urine drug screen positive; Drug screen positive
Item
Subject has a positive pre-study drug/urine screen.
boolean
C0743300 (UMLS CUI [1])
C0743295 (UMLS CUI [2])
Urine cotinine test
Item
Subject has a pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products.
boolean
C1697737 (UMLS CUI [1])
Drug usage; Vitamin supplementation; Dietary Supplements; Hormone replacement therapy
Item
Subject has used prescription or non-prescription drugs, vitamins, dietary/herbal supplements or hormone replacement therapy within 2 weeks prior to the first dose of study medication with the exception of acetaminophen, which may be used at label dosages as needed throughout the trial.
boolean
C0242510 (UMLS CUI [1])
C0302837 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0282402 (UMLS CUI [4])
exenatide; GLP-1 Mimetics; Antibody screen, Titer
Item
Has previously received exenatide or any other GLP-1 mimetic in a clinical trial, or has a positive antibody titer at Screening.
boolean
C0167117 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C0368676 (UMLS CUI [3,1])
C0475208 (UMLS CUI [3,2])
Blood donation
Item
The subject has donated 500 or more mL of blood within 56 days prior to dosing or has intention of donating blood in the month following the study.
boolean
C0005794 (UMLS CUI [1])
Family member, Research Personnel; Staff Member
Item
Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
boolean
C0086282 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1552089 (UMLS CUI [2])
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