Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

Study Overview
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Brief Summary
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The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride

Official Title
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An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components

Conditions
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Hypogonadism, Hypogonadism, Male

Intervention / Treatment
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* Drug: Nanomilled testosterone
* Drug: commercially available dutasteride
* Drug: Nanomilled dutasteride


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Are healthy. Have a BMI within range of 19-32 kg/m2. Have not taken dutasteride for one year, or finasteride for the past 3 months. Have a screening PSA < 2.0ng/mL. Exclusion criteria: Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition. Have a trigliceride level =500mg/dL. Have abnormal thyroid or hormone levels. Would donate more than 500 ML of blood over a 2 month period. Physician does not think it is a good idea for you to participate in the trial. Are unwilling to abstain from alcohol during the study. Have a positive urine drug screen test. Plan to change your smoking habits during the course of the trial. Have Hepatitis C, Hepatitis B, or HIV. Have a lab or ECG abnormality. Have high or low blood pressure. Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nanomilled testosterone|nan|
|Drug: commercially available dutasteride|nan|
|Drug: Nanomilled dutasteride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lab tests for relative bioavailability of testosterone and dutasteride, |  | days 1, 2, 3, 19, 20, 21 & 26-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety lab tests of various testosterone/dutasteride formulations, |  | days 1, 2, 3, 19, 20, 21 & 26-31. | 
| lab tests for additional pharmacokinetic parameters for testosterone & dutasteride, |  | days 1, 2, 3, 19, 20, 21 & 26-31. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency