ID

37343

Beskrivning

A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020); ODM derived from: https://clinicaltrials.gov/show/NCT02411929

Länk

https://clinicaltrials.gov/show/NCT02411929

Nyckelord

Versioner (1)
  1. 2019-07-18 2019-07-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02411929

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02411929

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subjects between the ages of 18 and 65 years.
Beskrivning

Healthy Volunteers | Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
body mass index (bmi) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs.)
Beskrivning

Body mass index | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).
Beskrivning

Hematological Disease | Kidney Disease | Endocrine System Disease | Lung disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorder | Nervous system disorder | Hypersensitivity | Drug Allergy | Exception Seasonal allergies Asymptomatic Untreated

Datatyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0004936
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0020517
UMLS CUI [11]
C0013182
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0018621
UMLS CUI [12,3]
C0231221
UMLS CUI [12,4]
C0332155
any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
Beskrivning

Malabsorption Syndrome | Gastrectomy | Bowel resection

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0017118
UMLS CUI [3]
C0741614
a positive urine drug screen for drugs of abuse or recreational drugs.
Beskrivning

Urine drug screen positive | Drug abuse | Recreational Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0242508
positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results.
Beskrivning

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
history of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
Beskrivning

Alcohol abuse | Binge Drinking | Illicit medication use | Drug Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0556346
UMLS CUI [3]
C0281875
UMLS CUI [4]
C1510472
current smokers and those who have smoked any substance within the last 12 months.
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
treatment with an investigational drug within 1 month preceding the first dose of study medication.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
have participated in any clinical study with exposure to 14^c in the last 12 months.
Beskrivning

Study Subject Participation Status | Exposure to 14-C

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0302945
any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. no occupationally exposed worker, as defined in the ionising radiation regulation 1999, shall participate in the study.
Beskrivning

Exposure to radiation | Exception Background Radiation | Diagnostic radiologic examination | Occupational exposure to radiation

Datatyp

boolean

Alias
UMLS CUI [1]
C0015333
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004607
UMLS CUI [3]
C0043299
UMLS CUI [4]
C1261238
use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication.
Beskrivning

Prescription Drugs | Drugs, Non-Prescription | Vitamins | Dietary Supplements

Datatyp

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C0242295
use of herbal supplements within 28 days prior to the first dose of study medication.
Beskrivning

Herbal Supplements

Datatyp

boolean

Alias
UMLS CUI [1]
C1504473
blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 56 days prior to dosing.
Beskrivning

Blood Donation Amount | Exception Plasma Donation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032105
UMLS CUI [2,3]
C0680854
participants who have previously participated in a clinical trial for ertugliflozin.
Beskrivning

Study Subject Participation Status | ertugliflozin

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C4079805
serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Beskrivning

Adverse reactions Serious Pharmaceutical Preparations | Drug Allergy Serious | Adverse reactions Serious Pharmaceutical Excipient | Hypersensitivity Serious Pharmaceutical Excipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0015237
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02411929

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Gender | Age
Item
healthy male subjects between the ages of 18 and 65 years.
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index | Body Weight
Item
body mass index (bmi) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs.)
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hematological Disease | Kidney Disease | Endocrine System Disease | Lung disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorder | Nervous system disorder | Hypersensitivity | Drug Allergy | Exception Seasonal allergies Asymptomatic Untreated
Item
evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).
boolean
C0018939 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0020517 (UMLS CUI [10])
C0013182 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C0018621 (UMLS CUI [12,2])
C0231221 (UMLS CUI [12,3])
C0332155 (UMLS CUI [12,4])
Malabsorption Syndrome | Gastrectomy | Bowel resection
Item
any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
boolean
C0024523 (UMLS CUI [1])
C0017118 (UMLS CUI [2])
C0741614 (UMLS CUI [3])
Urine drug screen positive | Drug abuse | Recreational Drugs
Item
a positive urine drug screen for drugs of abuse or recreational drugs.
boolean
C0743300 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0242508 (UMLS CUI [3])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Alcohol abuse | Binge Drinking | Illicit medication use | Drug Dependence
Item
history of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
boolean
C0085762 (UMLS CUI [1])
C0556346 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
C1510472 (UMLS CUI [4])
Tobacco use
Item
current smokers and those who have smoked any substance within the last 12 months.
boolean
C0543414 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with an investigational drug within 1 month preceding the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status | Exposure to 14-C
Item
have participated in any clinical study with exposure to 14^c in the last 12 months.
boolean
C2348568 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0302945 (UMLS CUI [2,2])
Exposure to radiation | Exception Background Radiation | Diagnostic radiologic examination | Occupational exposure to radiation
Item
any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. no occupationally exposed worker, as defined in the ionising radiation regulation 1999, shall participate in the study.
boolean
C0015333 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004607 (UMLS CUI [2,2])
C0043299 (UMLS CUI [3])
C1261238 (UMLS CUI [4])
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Dietary Supplements
Item
use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication.
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
Herbal Supplements
Item
use of herbal supplements within 28 days prior to the first dose of study medication.
boolean
C1504473 (UMLS CUI [1])
Blood Donation Amount | Exception Plasma Donation
Item
blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
C0680854 (UMLS CUI [2,3])
Study Subject Participation Status | ertugliflozin
Item
participants who have previously participated in a clinical trial for ertugliflozin.
boolean
C2348568 (UMLS CUI [1])
C4079805 (UMLS CUI [2])
Adverse reactions Serious Pharmaceutical Preparations | Drug Allergy Serious | Adverse reactions Serious Pharmaceutical Excipient | Hypersensitivity Serious Pharmaceutical Excipient
Item
serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
boolean
C0559546 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0013182 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0559546 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
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