Oral T7 Oral Testosterone in Man

Study Overview
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Brief Summary
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The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

Detailed Description
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We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week drug administration period. During the time when the body's production of testosterone is turned off, we will give testosterone either by itself or with a medication called finasteride by mouth twice daily for one week to see how much is absorbed and present in the bloodstream after administration. Subjects will go through three one-week study drug exposure periods. During two of the three one-week study drug administration periods subjects will also take a second medication, finasteride, by mouth twice daily. On the last day of each one-week drug administration period, subjects will be admitted to the University of Washington General Clinical Research Center overnight for monitoring of your blood testosterone levels. There will be 3 overnight visits for this study. This study will allow us to determine the absorption of testosterone taken by mouth, and the relative impact of two different doses of oral finasteride on testosterone absorption.

Official Title
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Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride

Conditions
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Healthy Males, Male Contraceptive

Intervention / Treatment
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* Drug: First Intervention (7 days)
* Other: First Washout (7 days)
* Drug: Second Intervention (7 days)
* Drug: Third Intervention (7 days)
* Other: Second wash-out period


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males between 18 and 50 years of age In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels. Must agree to not participate in another research drug study Must agree to not donate blood Must be willing to comply with the study protocol and procedures Exclusion Criteria: Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values) A known history of alcohol or drug abuse Participation in a long-term male contraceptive study within the past month History of bleeding disorders or current use of anti-coagulants History of sleep apnea History of major psychiatric disorder Body mass index > 37 Infertility Hematocrit > 55 or < 30 PSA >4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Testosterone Undecanoate + placebo finasteride<br>Acyline 300mcg/kg subcutaneous on days 1, 15 and 29 + Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days + placebo finasteride twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention) | Drug: First Intervention (7 days)<br>* Acyline 300mcg/kg subcutaneous (days 1, 15 & 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo<br>* Other names: propecia;Other: First Washout (7 days)<br>* Washout of 7 days between each of the 3 treatment arms<br>* Other names: no active drugs;|
| Experimental: Testosterone Undecanoate + Finasteride 0.5mg<br>Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 0.5mg twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention) | Drug: Second Intervention (7 days)<br>* Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally<br>* Other names: propecia;Other: Second wash-out period<br>* Washout of 7 days between each of the 3 treatment arms<br>* Other names: no active drug;|
| Experimental: Testosterone Undecanoate + Finasteride 1mg<br>Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 1mg twice daily, orally for 7 days during one of the three intervention periods ((First Intervention, Second Intervention or Third Intervention) | Drug: Third Intervention (7 days)<br>* Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally<br>* Other names: propecia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Testosterone Concentration | Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration. | 0,1,2,4,8,and 12-hour post dose | 
| Serum Dihydrotestosterone Concentration | Area under the curve of serum dihydrotestosterone | 0,1,2,4,8,and 12-hour post dose | 
| Serum Estradiol Concentration | Area under the curve of serum estradiol | 0,1,2,4,8,and 12-hour post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5α-reductase, androgen, dihydrotestosterone (DHT), drug delivery, oestradiol