ID

39372

Beschreibung

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A; ODM derived from: https://clinicaltrials.gov/show/NCT01724814

Link

https://clinicaltrials.gov/show/NCT01724814

Stichworte

Versionen (1)
  1. 03.01.20 03.01.20 -
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See clinicaltrials.gov

Hochgeladen am

3. Januar 2020

DOI

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Eligibility Healthy NCT01724814

Englisch

Eligibility Healthy NCT01724814

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01724814
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy subjects
Beschreibung

Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
age ≥18 and ≤70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
Beschreibung

Obesity Absent | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1305855
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
Beschreibung

General health good Medical History | General health good Physical Examination | General health good Biochemical finding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C0428132
non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
Beschreibung

Non-smoker | Light tobacco smoker Number of cigarettes per day | Ability Refrain from Smoking

Datentyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C3494624
UMLS CUI [2,2]
C3694146
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C4086797
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
Beschreibung

Pregnancy Absent | Breast Feeding Absent | Female Sterilization | Tubal Occlusion | Hysterectomy | Bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state Duration | Male sterilization | Gender Sexual Abstinence | Partner Childbearing Potential | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0041275
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0195509
UMLS CUI [7]
C0278321
UMLS CUI [8,1]
C0232970
UMLS CUI [8,2]
C0449238
UMLS CUI [9]
C0024559
UMLS CUI [10,1]
C0079399
UMLS CUI [10,2]
C0036899
UMLS CUI [11,1]
C0682323
UMLS CUI [11,2]
C3831118
UMLS CUI [12,1]
C0079399
UMLS CUI [12,2]
C0700589
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous participation in this trial or other clinical trials within the last 3 months.
Beschreibung

Study Subject Participation Status | Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
clinically significant abnormal hematology or biochemistry screening tests, as judged by the investigator. in particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (ast or alt >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
Beschreibung

Haematology test abnormal | Abnormal Laboratory Result (Biochemistry) | Elevated liver enzymes | Healthy Volunteers | Diabetes Mellitus | Aspartate aminotransferase increased | Alanine aminotransferase increased | Renal Insufficiency | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C1112712
UMLS CUI [2]
C0281768
UMLS CUI [3]
C0235996
UMLS CUI [4]
C1708335
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
UMLS CUI [8]
C1565489
UMLS CUI [9]
C0700225
history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. in particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
Beschreibung

Illness Interferes with Research results | Illness Investigational New Drugs At risk | Cardiovascular Diseases | Anemia | Decreased hemoglobin | Hemoglobinopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0002871
UMLS CUI [5]
C1821769
UMLS CUI [6]
C0019045
clinically significant abnormal ecg at screening, as judged by the investigator.
Beschreibung

ECG abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
history of alcohol abuse.
Beschreibung

Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
any positive reaction of drugs of abuse.
Beschreibung

Drug abuse Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C1514241
hepatitis b or c or hiv positive.
Beschreibung

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.
Beschreibung

Prescription Drugs | Exception Pharmaceutical Preparations Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348563
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Ähnliche Modelle

Eligibility Healthy NCT01724814

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Healthy NCT01724814
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
healthy subjects
boolean
C1708335 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Obesity Absent | Body mass index
Item
non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
boolean
C0028754 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
General health good Medical History | General health good Physical Examination | General health good Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0428132 (UMLS CUI [3,2])
Non-smoker | Light tobacco smoker Number of cigarettes per day | Ability Refrain from Smoking
Item
non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
boolean
C0337672 (UMLS CUI [1])
C3494624 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3,1])
C4086797 (UMLS CUI [3,2])
Pregnancy Absent | Breast Feeding Absent | Female Sterilization | Tubal Occlusion | Hysterectomy | Bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state Duration | Male sterilization | Gender Sexual Abstinence | Partner Childbearing Potential | Gender Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0041275 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0195509 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0232970 (UMLS CUI [8,1])
C0449238 (UMLS CUI [8,2])
C0024559 (UMLS CUI [9])
C0079399 (UMLS CUI [10,1])
C0036899 (UMLS CUI [10,2])
C0682323 (UMLS CUI [11,1])
C3831118 (UMLS CUI [11,2])
C0079399 (UMLS CUI [12,1])
C0700589 (UMLS CUI [12,2])
Informed Consent
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trials
Item
previous participation in this trial or other clinical trials within the last 3 months.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Haematology test abnormal | Abnormal Laboratory Result (Biochemistry) | Elevated liver enzymes | Healthy Volunteers | Diabetes Mellitus | Aspartate aminotransferase increased | Alanine aminotransferase increased | Renal Insufficiency | Serum creatinine raised
Item
clinically significant abnormal hematology or biochemistry screening tests, as judged by the investigator. in particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (ast or alt >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
boolean
C1112712 (UMLS CUI [1])
C0281768 (UMLS CUI [2])
C0235996 (UMLS CUI [3])
C1708335 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C1565489 (UMLS CUI [8])
C0700225 (UMLS CUI [9])
Illness Interferes with Research results | Illness Investigational New Drugs At risk | Cardiovascular Diseases | Anemia | Decreased hemoglobin | Hemoglobinopathy
Item
history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. in particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C1821769 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
ECG abnormal
Item
clinically significant abnormal ecg at screening, as judged by the investigator.
boolean
C0522055 (UMLS CUI [1])
Alcohol abuse
Item
history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Drug abuse Positive
Item
any positive reaction of drugs of abuse.
boolean
C0013146 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
hepatitis b or c or hiv positive.
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Prescription Drugs | Exception Pharmaceutical Preparations Study Protocol
Item
use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.
boolean
C0304227 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
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