Pharmacokinetic Study of Testosterone Enanthate

Study Overview
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Brief Summary
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Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed Description
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Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm. Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Official Title
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3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: QuickShot™ - 50 mg Treatment B
* Drug: QuickShot™ - 100 mg Treatment A
* Drug: Delatestryl 200 mg IM Treatment C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males aged 18 to 75 with a documented diagnosis of hypogonadism Exclusion Criteria: Normal testosterone levels Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuickShot™ - 100 mg Treatment A<br>QuickShot™Testosterone - Auto-injector device for SC use | Drug: QuickShot™ - 100 mg Treatment A<br>* QuickShot™ for the delivery of testosterone<br>* Other names: Testosterone enanthate;|
| Experimental: QuickShot™ - 50 mg Treatment B<br>QuickShot™Testosterone- Auto-injector device for SC use | Drug: QuickShot™ - 50 mg Treatment B<br>* QuickShot™ for the delivery of testosterone<br>* Other names: Testosterone enanthate;|
| Active Comparator: Delatestryl 200 mg IM Treatment C<br>Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference | Drug: Delatestryl 200 mg IM Treatment C<br>* Standard of care<br>* Other names: Testosterone enanthate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks | The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks | 
| The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks | The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks | 
| The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks | The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients in the PK Parameter Category | The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogonadism, Testosterone enanthate