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Pharmacokinetic Study of Testosterone

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ClinicalTrials.gov Identifier: NCT02233751
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Brief Summary:
Evaluation of pharmacokinetic and safety profile of testosterone after a single dose using auto-injector

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone enanthate auto-injector Phase 1

Detailed Description:
Evaluation of single-dose pharmacokinetics in healthy male volunteers

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: Treatment A
Testosterone enanthate auto-injector (SC injection)
Drug: Testosterone enanthate auto-injector
Randomization of Treatment A; or Treatment B
Other Names:
  • Testosterone
  • Testosterone enanthate
  • QuickShot® Testosterone (QST)

Experimental: Treatment B
Testosterone enanthate auto-injector (SC injections)
Drug: Testosterone enanthate auto-injector
Randomization of Treatment A; or Treatment B
Other Names:
  • Testosterone
  • Testosterone enanthate
  • QuickShot® Testosterone (QST)




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  2. Area under the concentration-time curve from time zero to time t (AUC0-t) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  3. Area under the concentration-time curve from time zero to time inf (AUC0-inf) [ Time Frame: Pre-dose through 168 hours post-dose. ]

Secondary Outcome Measures :
  1. Time to maximum concentration (tmax) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  2. Elimination rate constant (kel) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  3. Half-life (t1/2) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  4. Clearance (CL/F) [ Time Frame: Pre-dose through 168 hours post-dose. ]
  5. Apparent volume of distribution (Vd/F) [ Time Frame: Pre-dose through 168 hours post-dose. ]

Other Outcome Measures:
  1. Safety [ Time Frame: 14 days ]
    • Incidence of Adverse events, including injection site reactions
    • Assessment of Clinical laboratory measurements; Vital signs; 12-lead electrocardiograms and Physical examinations



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233751


Locations
United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Antares Pharma Inc.

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT02233751     History of Changes
Other Study ID Numbers: QST-14-004
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: November 2014

Keywords provided by Antares Pharma Inc.:
Healthy Adult Males

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents