Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone enanthate auto-injector
Intervention description: Randomization then administration of combination product study medication according to group assignment
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: The dose assignment was random among the enrolled participants.
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Adult Males

Summary:

      Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
    

Eligibility criteria:

        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