Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Study Overview
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Brief Summary
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Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Detailed Description
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Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers

Official Title
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An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects

Conditions
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Hypogonadism

Intervention / Treatment
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* Combination Product: Testosterone enanthate auto-injector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent; Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening; Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram [ECG], physical examination, and laboratory tests); and Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed. Exclusion Criteria: Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders; History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values; PSA level > 3 ng/ml at screening; Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines; Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in; Abnormal ECG at screening as judged by the Investigator; History of clinically significant drug and/or food allergies as determined by the Investigator; Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic reaction to compounds related to the study drug Subjects undergoing current treatment with other androgens (i.e. dehydroepiandrosterone [DHEA]), anabolic steroids, other sex hormones, or drugs that interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone); Subjects treated within the past 12 months with estrogens, gonadotropin releasing hormone (GnRH) agonists, or growth hormone; Prescription, over the counter medications, vitamins, herbal and dietary supplements taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication and duration of the study; Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at screening; Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive breath alcohol test at screening and check-in

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone enanthate auto-injector - 50 mg<br>Testosterone enanthate auto-injector - 50 mg (SC injection) | Combination Product: Testosterone enanthate auto-injector<br>* Randomization then administration of combination product study medication according to group assignment<br>|
| Experimental: Testosterone enanthate auto-injector - 200 mg<br>Testosterone enanthate auto-injector- 200 mg (SC injection) | Combination Product: Testosterone enanthate auto-injector<br>* Randomization then administration of combination product study medication according to group assignment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate | Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate | Maximum serum concentrations occurring during an 8 days study window | 
| Area Under the Concentration-time Curve From Time Zero to Time t | AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week); | 168 hrs | 
| Area Under the Concentration-time Curve From Time Zero to Infinity | AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity | time zero to infinity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Concentration (Tmax)(hr) | tmax = Time to reach maximum concentration | The sample time of Cmax during a 168 hour sampling interval | 
| Half-life (t 1/2)(hr) | t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value | 168 hours | 
| Clearance CL/F (L/hr) | Clearance - volume of plasma from which TT/TE is completely removed per unit time | 168 hours | 
| Vd/F (L) | Vd/F (L) = Apparent volume of distribution | 168 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Adult Males