Description:

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

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Versions (4) ▾
  1. 10/22/18
  2. 1/14/19
  3. 3/4/19
  4. 4/13/21
Copyright Holder:
GlaxoSmithKline
Uploaded on:

April 13, 2021

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License:
Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Part 2 - Screening Visit - Eligibility Criteria

Administrative data
Eligibility Question
Did the subject meet all the entry criteria?
Inclusion Criteria
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.)
Subjects are between the ages of 18 and 50 years old inclusive at the time of signing the informed consent.
Body weight ≥ 45 kg (99lbs) and BMI within the range 21-32kg/m2 inclusive.
Read, comprehend, and write English at the sufficient level to complete study-related materials.
A signed and dated written informed consent prior to admission to the study.
The subject is able to understand and comply with protocol requierements, instructions and protocol-stated restrictions.
Subject has not taken dutasteride for one year, and finasteride in the past 3 month.
Screening PSA < 2.0ng/mL.
Exclusion Criteria
As a result of medical interview, physical examination,or screening investigations, the Investigator considers the subject unfit for the study.
History of sleep apnea
History of significant psychiatric problems such as severe depression.
History of carcinoma of the breast or prostate.
Has a positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result.
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.
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.
The subject has a triglyceride level >=500 mg/dL.
The subject has an abnormal thyroid function test assessed by TSH and free T4 at screening and/or is taking thyroxine.
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.
The subject has a hemoglobin level >18.0gm/L.
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.
Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until final post-dose assessment during each session.
Smoked or used tobacco or nicotine-containing products within the previous 6 month (no exceptions)
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).
Unwilling to refrain from the use of illicit drugs or adhere to other protocol-stated restrictions while participating in the study.
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.
Consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication until final post-dose assessments.
Unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment during each session.
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.
Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period.
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.
Abnormal reproductive hormone levels (total and free testosterone, LH, FSH)

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