Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Phase 1

Completed

Conditions: Hypogonadism

Interventions: Combination Product: Testosterone enanthate auto-injector

Registration Number: NCT02233751

Lead Sponsor: Antares Pharma Inc.

Brief Summary: Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone enanthate auto-injector - 200 mg	Testosterone enanthate auto-injector	Testosterone enanthate auto-injector- 200 mg (SC injection)
Testosterone enanthate auto-injector - 50 mg	Testosterone enanthate auto-injector	Testosterone enanthate auto-injector - 50 mg (SC injection)

Primary Outcome Measures

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

Secondary Outcome Measures

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