Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

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

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Combination product: Testosterone enanthate auto-injector

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Antares Pharma Inc.
• Investigators: Study Director: Jonathan Jaffe, MD, Antares Pharma Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Healthy Adult Males
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: QST-14-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes