ID

29172

Descripción

Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00933062

Link

https://clinicaltrials.gov/show/NCT00933062

Palabras clave

Versiones (1)
  1. 4/3/18 4/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00933062

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00933062

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
be a healthy male within the age range of 18 to 60 years.
Descripción

Healthy Volunteer | Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
voluntarily sign a research ethics committee (rec)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
have biochemistry, coagulation, haematology and urinalysis test results that are within normal, allowable limits (if out-of-range, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of test material.
Descripción

Biochemistry Normal | Blood coagulation tests Normal | Hematology procedure Normal | Urinalysis Normal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428132
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0005790
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0200627
UMLS CUI [3,2]
C0205307
UMLS CUI [4,1]
C0042014
UMLS CUI [4,2]
C0205307
have a bmi (body mass index) between 18.0 and 32.0 kg/m2.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
be clear of any history of hiv and hepatitis b and c.
Descripción

HIV Infection Free of | Hepatitis B Free of | Hepatitis C Free of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0332296
have no significant disease or clinically significant abnormal laboratory value as deemed by the investigator on the laboratory evaluations, medical history, or physical exam.
Descripción

Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0031809
have a normal 12-lead ecg or an ecg with abnormality considered to be clinically insignificant.
Descripción

12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C2826293
have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Descripción

Able to communicate Research Personnel | Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C0525058
agree to use an acceptable double barrier method for birth control from the screening visit through 3 months after the last dose of test material.
Descripción

Agreement Barrier Contraception Double

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
agree to refrain from consumption of grapefruits and/or grapefruit juice from 7 days prior to day -1 of treatment visit 1 through to the end of subject's final study visit on day 29.
Descripción

Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0995150
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0452456
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the investigator would deem unfavourable for enrolment.
Descripción

Illness Major Enrollment Unfavorable | Chronic disease Enrollment Unfavorable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1516879
UMLS CUI [1,4]
C3640815
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1516879
UMLS CUI [2,3]
C3640815
subject has renal or liver impairment.
Descripción

Renal Insufficiency | Hepatic impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0948807
subject has a history of gastro-intestinal surgery or has a current gastrointestinal disease which may influence drug absorption.
Descripción

Gastrointestinal Surgical Procedure | Gastrointestinal Diseases Influence Drug absorption

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0678745
subject has a history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc) or a positive drug result at the screening visit.
Descripción

Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol | Drug screen positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0242402
UMLS CUI [4]
C0002667
UMLS CUI [5]
C0009170
UMLS CUI [6]
C0039663
UMLS CUI [7]
C0743295
subject smokes more than 5 cigarettes a day.
Descripción

Tobacco use Number of cigarettes per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
subject has a history of alcoholism, and/or is currently drinking more than three drinks per day [one drink is equal to one unit of alcohol (one glass of wine, half a pint of beer, one measure of a spirit)].
Descripción

Alcoholic Intoxication, Chronic | Alcohol consumption Alcoholic Beverages Quantity per day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0001967
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0439505
subject has participated in a clinical trial within the past three months (defined as three months from the date of last dose of an investigational medicinal product), with the exception of the srt-2104-004 study (eudract number: 2008-007364-41).
Descripción

Study Subject Participation Status | Exception Clinical Trial Specified

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
subject has a history of difficulty in donating blood or accessibility of veins in left or right arm.
Descripción

Blood Donation Difficult | Access Via arm vein Difficult

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332218
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0442444
UMLS CUI [2,3]
C0332218
subject has donated blood (one unit or 350 ml) within three months prior to receiving test material.
Descripción

Blood Donation Unit Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C1265611
subject is taking herbal products, over-the-counter medication or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the screening period) prior to enrolment into the study.
Descripción

Plant product | Drugs, Non-Prescription | Pharmacotherapy | Drug half-life Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032088
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0013216
UMLS CUI [4,1]
C0678761
UMLS CUI [4,2]
C0449238
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00933062

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteer | Gender | Age
Item
be a healthy male within the age range of 18 to 60 years.
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Informed Consent
Item
voluntarily sign a research ethics committee (rec)-approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.
boolean
C0021430 (UMLS CUI [1])
Biochemistry Normal | Blood coagulation tests Normal | Hematology procedure Normal | Urinalysis Normal
Item
have biochemistry, coagulation, haematology and urinalysis test results that are within normal, allowable limits (if out-of-range, must be considered clinically significant to be exclusionary) and performed within 21 days of receiving first dose of test material.
boolean
C0428132 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005790 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0200627 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0042014 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
Body mass index
Item
have a bmi (body mass index) between 18.0 and 32.0 kg/m2.
boolean
C1305855 (UMLS CUI [1])
HIV Infection Free of | Hepatitis B Free of | Hepatitis C Free of
Item
be clear of any history of hiv and hepatitis b and c.
boolean
C0019693 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination
Item
have no significant disease or clinically significant abnormal laboratory value as deemed by the investigator on the laboratory evaluations, medical history, or physical exam.
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance
Item
have a normal 12-lead ecg or an ecg with abnormality considered to be clinically insignificant.
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Able to communicate Research Personnel | Protocol Compliance
Item
have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Agreement Barrier Contraception Double
Item
agree to use an acceptable double barrier method for birth control from the screening visit through 3 months after the last dose of test material.
boolean
C0680240 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Avoidance Grapefruit | Avoidance GRAPEFRUIT JUICE
Item
agree to refrain from consumption of grapefruits and/or grapefruit juice from 7 days prior to day -1 of treatment visit 1 through to the end of subject's final study visit on day 29.
boolean
C0870186 (UMLS CUI [1,1])
C0995150 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0452456 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Illness Major Enrollment Unfavorable | Chronic disease Enrollment Unfavorable
Item
subject has had a major illness in the past three months or any significant ongoing chronic medical illness that the investigator would deem unfavourable for enrolment.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Renal Insufficiency | Hepatic impairment
Item
subject has renal or liver impairment.
boolean
C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
Gastrointestinal Surgical Procedure | Gastrointestinal Diseases Influence Drug absorption
Item
subject has a history of gastro-intestinal surgery or has a current gastrointestinal disease which may influence drug absorption.
boolean
C0524722 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol | Drug screen positive
Item
subject has a history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc) or a positive drug result at the screening visit.
boolean
C0013146 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0002667 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0039663 (UMLS CUI [6])
C0743295 (UMLS CUI [7])
Tobacco use Number of cigarettes per day
Item
subject smokes more than 5 cigarettes a day.
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Alcoholic Intoxication, Chronic | Alcohol consumption Alcoholic Beverages Quantity per day
Item
subject has a history of alcoholism, and/or is currently drinking more than three drinks per day [one drink is equal to one unit of alcohol (one glass of wine, half a pint of beer, one measure of a spirit)].
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
Study Subject Participation Status | Exception Clinical Trial Specified
Item
subject has participated in a clinical trial within the past three months (defined as three months from the date of last dose of an investigational medicinal product), with the exception of the srt-2104-004 study (eudract number: 2008-007364-41).
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Blood Donation Difficult | Access Via arm vein Difficult
Item
subject has a history of difficulty in donating blood or accessibility of veins in left or right arm.
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0442444 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Blood Donation Unit Quantity
Item
subject has donated blood (one unit or 350 ml) within three months prior to receiving test material.
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Plant product | Drugs, Non-Prescription | Pharmacotherapy | Drug half-life Duration
Item
subject is taking herbal products, over-the-counter medication or prescription drug therapy for which 5 times the half-life is longer than 21 days (i.e., the screening period) prior to enrolment into the study.
boolean
C0032088 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
C0678761 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
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