Clinical trial NCT02233751: Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Keywords: Healthy Adult Males
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
timeFrame: Maximum serum concentrations occurring during an 8 days study window
measure: Area Under the Concentration-time Curve From Time Zero to Time t
timeFrame: 168 hrs
measure: Area Under the Concentration-time Curve From Time Zero to Infinity
timeFrame: time zero to infinity
Secondary outcomes:
measure: Time to Maximum Concentration (Tmax)(hr)
timeFrame: The sample time of Cmax during a 168 hour sampling interval
measure: Half-life (t 1/2)(hr)
timeFrame: 168 hours
measure: Clearance CL/F (L/hr)
timeFrame: 168 hours
measure: Vd/F (L)
timeFrame: 168 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
affiliation: Antares Pharma Inc.
name: Jonathan Jaffe, MD
role: STUDY_DIRECTOR
References: