Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Completed · Phase 1

Conditions studied: Hypogonadism

In brief

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Key facts

Study ID

NCT02233751

Run by

Antares Pharma Inc.

People needed

12

Starts

2014-09-01

Expected to finish

2014-10-01

Last updated by the study team

2019-04-19

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.