Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233751
• Other study ID #: QST-14-004
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2019
• Source: Antares Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Combination Product:
• Testosterone enanthate auto-injector
Randomization then administration of combination product study medication according to group assignment

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology Unit	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Antares Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Time to Maximum Concentration (Tmax)(hr)	tmax = Time to reach maximum concentration	The sample time of Cmax during a 168 hour sampling interval
Secondary	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
Secondary	Clearance CL/F (L/hr)	Clearance - volume of plasma from which TT/TE is completely removed per unit time	168 hours
Secondary	Vd/F (L)	Vd/F (L) = Apparent volume of distribution	168 hours