ID

44765

Beskrivning

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Nyckelord

Versioner (5)
  1. 2018-10-22 2018-10-22 -
  2. 2019-01-14 2019-01-14 -
  3. 2019-03-04 2019-03-04 -
  4. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  5. 2021-11-17 2021-11-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 november 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Engelsk

Part 2 - Screening Visit - Eligibility Criteria

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Beskrivning

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beskrivning

Eligibility Determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
The subject is a healthy male (NOTE: Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by a responsible physician, no abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. No subjects with impaired renal or hepatic function. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the GSK Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.)
Beskrivning

Gender, Health Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0018759
Subjects are between the ages of 18 and 50 years old inclusive at the time of signing the informed consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Body weight ≥ 45 kg (99lbs) and BMI within the range 21-32kg/m2 inclusive.
Beskrivning

Body weight, Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Read, comprehend, and write English at the sufficient level to complete study-related materials.
Beskrivning

English Language

Datatyp

boolean

Alias
UMLS CUI [1]
C0376245
A signed and dated written informed consent prior to admission to the study.
Beskrivning

Informed Consent

Datatyp

boolean

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

Comprehension, Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0162340
UMLS CUI [2]
C0525058
Subject has not taken dutasteride for one year, and finasteride in the past 3 month.
Beskrivning

Duasteride, Finasteride

Datatyp

boolean

Alias
UMLS CUI [1]
C0754659
UMLS CUI [2]
C0060389
Screening PSA < 2.0ng/mL.
Beskrivning

Prostate Specific Antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Medically unfit, Clinical Research

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0008972
History of sleep apnea
Beskrivning

Sleep Apnea Syndromes

Datatyp

boolean

Alias
UMLS CUI [1]
C0037315
History of significant psychiatric problems such as severe depression.
Beskrivning

Psychiatric problem

Datatyp

boolean

Alias
UMLS CUI [1]
C1306597
History of carcinoma of the breast or prostate.
Beskrivning

Breast Carcinoma, Prostate Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0600139
Has a positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
Systolic blood pressure is outside the range of 95 to 150 mmHg, diastolic blood pressure is outside the range of 55 to 90 mmHg and/or heart rate is outside the range of 40 to 100 bpm.
Beskrivning

Systolic Pressure, Diastolic blood pressure, Heart rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0018810
12-lead ECG intervals are outside of acceptable of variation limits (PR interval>300msec; QRS interval>200 msec; QTb>440 msec), or other clinically significant findings.
Beskrivning

12-lead ECG, PR interval; 12-lead ECG, QRS Complex Duration; 12-lead ECG, QTcB

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C0429025
UMLS CUI [3,1]
C0430456
UMLS CUI [3,2]
C1882512
The subject has a triglyceride level >=500 mg/dL.
Beskrivning

Triglyceride level

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
The subject has an abnormal thyroid function test assessed by TSH and free T4 at screening and/or is taking thyroxine.
Beskrivning

Thyroid function tests abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0476414
The subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct (conjugated) bilirubin, alkaline phosphatase values 1.5-fold higher than the upper limit of normal at screening.
Beskrivning

Aspartate aminotransferase measurement, Alanine aminotransferase measurement, Serum conjugated bilirubin measurement, Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278038
UMLS CUI [4]
C0201850
The subject has a hemoglobin level >18.0gm/L.
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
History of alcohol abuse defined as an average weekly intake of greater than 21 units or n average of daily intake of greater than 3 units. One unit is equivalent to a halfpint of beer or 1 measure of spirits or 1 glass of wine.
Beskrivning

Alcohol Abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until final post-dose assessment during each session.
Beskrivning

Alcohol Abstinence, Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0558080
Smoked or used tobacco or nicotine-containing products within the previous 6 month (no exceptions)
Beskrivning

Smoking History, Tobacco use; Nicotine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C0543414
UMLS CUI [2]
C0028040
Has had treatment with a new molecular entity (investigational drug) or any other drug trial during the previous 2 month, or five-half lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3 (the washout is from last dose of study medication in the previous study until the first dose of study medication in this study).
Beskrivning

Study Subject Participation Status, Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Unwilling to refrain from the use of illicit drugs or adhere to other protocol-stated restrictions while participating in the study.
Beskrivning

Drug Abstinence, Unwilling, Compliance Behaviour

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237443
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C1321605
Use of prescription or non-prescription drugs, including St. John's Wort and dietary/herbal supplements (particularly those including phytoestrogens such as soybeans, tofy, black cohosh and red clover) within 14 days prior to the first dose of study medication with the exception of acetaminophen which may be used up to 72 hours prior to dosing.
Beskrivning

Pharmaceutical Preparations, Dietary Supplements, Herbal Supplements

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0242295
UMLS CUI [3]
C1504473
Consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication until final post-dose assessments.
Beskrivning

Grapefruit, Grapefruit juice

Datatyp

boolean

Alias
UMLS CUI [1]
C0995150
UMLS CUI [2]
C0452456
Unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment during each session.
Beskrivning

Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling

Datatyp

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
The subject has a positive pre-study urine drug, cotinine, or alcohol screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
Beskrivning

Urine drug screening, Urine cotinine test, Ethanol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2]
C1697737
UMLS CUI [3]
C0202304
Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period.
Beskrivning

Blood Donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
History of presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
Beskrivning

Experimental drug, Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
Abnormal reproductive hormone levels (total and free testosterone, LH, FSH)
Beskrivning

Reproductive Hormone, Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0597376
UMLS CUI [1,2]
C0205161
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Similar models

Part 2 - Screening Visit - Eligibility Criteria

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
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)
Gender, Health Status
Item
The subject is a healthy male (NOTE: Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by a responsible physician, no abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. No subjects with impaired renal or hepatic function. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the GSK Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.)
boolean
C0079399 (UMLS CUI [1])
C0018759 (UMLS CUI [2])
Age
Item
Subjects are between the ages of 18 and 50 years old inclusive at the time of signing the informed consent.
boolean
C0001779 (UMLS CUI [1])
Body weight, Body mass index
Item
Body weight ≥ 45 kg (99lbs) and BMI within the range 21-32kg/m2 inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
English Language
Item
Read, comprehend, and write English at the sufficient level to complete study-related materials.
boolean
C0376245 (UMLS CUI [1])
Informed Consent
Item
A signed and dated written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Comprehension, Protocol Compliance
Item
The subject is able to understand and comply with protocol requierements, instructions and protocol-stated restrictions.
boolean
C0162340 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Duasteride, Finasteride
Item
Subject has not taken dutasteride for one year, and finasteride in the past 3 month.
boolean
C0754659 (UMLS CUI [1])
C0060389 (UMLS CUI [2])
Prostate Specific Antigen measurement
Item
Screening PSA < 2.0ng/mL.
boolean
C0201544 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Medically unfit, Clinical Research
Item
As a result of 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])
Sleep Apnea Syndromes
Item
History of sleep apnea
boolean
C0037315 (UMLS CUI [1])
Psychiatric problem
Item
History of significant psychiatric problems such as severe depression.
boolean
C1306597 (UMLS CUI [1])
Breast Carcinoma, Prostate Carcinoma
Item
History of carcinoma of the breast or prostate.
boolean
C0678222 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive
Item
Has a positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Systolic Pressure, Diastolic blood pressure, Heart rate
Item
Systolic blood pressure is outside the range of 95 to 150 mmHg, diastolic blood pressure is outside the range of 55 to 90 mmHg and/or heart rate is outside the range of 40 to 100 bpm.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0018810 (UMLS CUI [3])
12-lead ECG, PR interval; 12-lead ECG, QRS Complex Duration; 12-lead ECG, QTcB
Item
12-lead ECG intervals are outside of acceptable of variation limits (PR interval>300msec; QRS interval>200 msec; QTb>440 msec), or other clinically significant findings.
boolean
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C0429025 (UMLS CUI [2,2])
C0430456 (UMLS CUI [3,1])
C1882512 (UMLS CUI [3,2])
Triglyceride level
Item
The subject has a triglyceride level >=500 mg/dL.
boolean
C0202236 (UMLS CUI [1])
Thyroid function tests abnormal
Item
The subject has an abnormal thyroid function test assessed by TSH and free T4 at screening and/or is taking thyroxine.
boolean
C0476414 (UMLS CUI [1])
Aspartate aminotransferase measurement, Alanine aminotransferase measurement, Serum conjugated bilirubin measurement, Alkaline phosphatase measurement
Item
The subject has aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct (conjugated) bilirubin, alkaline phosphatase values 1.5-fold higher than the upper limit of normal at screening.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278038 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Hemoglobin measurement
Item
The subject has a hemoglobin level >18.0gm/L.
boolean
C0518015 (UMLS CUI [1])
Alcohol Abuse
Item
History of alcohol abuse defined as an average weekly intake of greater than 21 units or n average of daily intake of greater than 3 units. One unit is equivalent to a halfpint of beer or 1 measure of spirits or 1 glass of wine.
boolean
C0085762 (UMLS CUI [1])
Alcohol Abstinence, Unwilling
Item
Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until final post-dose assessment during each session.
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Smoking History, Tobacco use; Nicotine
Item
Smoked or used tobacco or nicotine-containing products within the previous 6 month (no exceptions)
boolean
C1519384 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2])
Study Subject Participation Status, Investigational New Drugs
Item
Has had treatment with a new molecular entity (investigational drug) or any other drug trial during the previous 2 month, or five-half lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3 (the washout is from last dose of study medication in the previous study until the first dose of study medication in this study).
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Drug Abstinence, Unwilling, Compliance Behaviour
Item
Unwilling to refrain from the use of illicit drugs or 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 [1,3])
Pharmaceutical Preparations, Dietary Supplements, Herbal Supplements
Item
Use of prescription or non-prescription drugs, including St. John's Wort and dietary/herbal supplements (particularly those including phytoestrogens such as soybeans, tofy, black cohosh and red clover) within 14 days prior to the first dose of study medication with the exception of acetaminophen which may be used up to 72 hours prior to dosing.
boolean
C0013227 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
Grapefruit, Grapefruit juice
Item
Consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication until final post-dose assessments.
boolean
C0995150 (UMLS CUI [1])
C0452456 (UMLS CUI [2])
Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling
Item
Unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment during each session.
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 screening, Urine cotinine test, Ethanol measurement
Item
The subject has a positive pre-study urine drug, cotinine, or alcohol screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
boolean
C0202274 (UMLS CUI [1])
C1697737 (UMLS CUI [2])
C0202304 (UMLS CUI [3])
Blood Donation
Item
Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period.
boolean
C0005794 (UMLS CUI [1])
Experimental drug, Hypersensitivity
Item
History of presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Reproductive Hormone, Abnormal
Item
Abnormal reproductive hormone levels (total and free testosterone, LH, FSH)
boolean
C0597376 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
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