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])
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])