Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Study Overview
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Brief Summary
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The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Detailed Description
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Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Official Title
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Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men

Conditions
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Male Hypogonadism

Intervention / Treatment
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* Drug: Oral testosterone undecanoate (containing 300 mg T)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age 18-65 Morning serum testosterone (T) <300 ng/dL on two occasions Exclusion Criteria: Significant intercurrent disease Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer. Serum transaminases >2 times upper limit of normal Serum bilirubin >2.0 mg/dL Hematocrit <35% or >50% BMI >36 Untreated, obstructive sleep apnea.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting (Treatment A)<br>Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state | Drug: Oral testosterone undecanoate (containing 300 mg T)<br> <br> |
| Experimental: Very low fat diet (Treatment B)<br>Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of  800 calories with very low fat (6-10% fat). | Drug: Oral testosterone undecanoate (containing 300 mg T)<br> <br> |
| Experimental: Low fat diet (Treatment C)<br>Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of  800 calories with low fat (20% fat). | Drug: Oral testosterone undecanoate (containing 300 mg T)<br> <br> |
| Experimental: Normal diet (Treatment D)<br>Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of  800 calories with normal fat (30% fat). | Drug: Oral testosterone undecanoate (containing 300 mg T)<br> <br> |
| Experimental: High fat diet (Treatment E)<br>Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of  800 calories with high fat (50% fat). | Drug: Oral testosterone undecanoate (containing 300 mg T)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25. | 25 hour serial blood draws separated by 4 to 10 days of washout between treatments. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary hypogonadism, Secondary hypogonadism