NCT02233751已完成1 期
An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Area Under the Concentration-time Curve From Time Zero to Time t
研究概览
简要总结
Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
详细描述
Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The dose assignment was random among the enrolled participants.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Area Under the Concentration-time Curve From Time Zero to Time t
时间窗: 168 hrs
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
Area Under the Concentration-time Curve From Time Zero to Infinity
时间窗: time zero to infinity
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
时间窗: Maximum serum concentrations occurring during an 8 days study window
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
次要结局
- Clearance CL/F (L/hr)(168 hours)
- Half-life (t 1/2)(hr)(168 hours)
- Time to Maximum Concentration (Tmax)(hr)(The sample time of Cmax during a 168 hour sampling interval)
- Vd/F (L)(168 hours)
研究者
研究点 (2)
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