A Study to Assess Post-collection Conversion of Testosterone Undecanoate (TU) to Testosterone in Blood From Men Receiving Oral TU Collected Into Different Types of Sample Tubes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
研究概览
简要总结
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
详细描述
This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures [room temperature or on ice] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects were required to meet all of the following criteria in order to be eligible for the study:
- •Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
- •Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
- •Naïve to androgen-replacement therapy
- •Willing to consume the entire protocol-specified breakfast and dinner meals
- •Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg
- •Voluntarily gave written informed consent to participate in this study -
排除标准
- •Subjects who met any of the following criteria were not eligible for participation in this study:
- •History of hypertension or taking anti-hypertensive medications
- •Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
- •Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
- •Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
- •Current use of the following groups of drugs that affect testosterone levels, testosterone metabolism, or levels of testosterone metabolites, namely antiandrogens, 5 alpha reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride), or human growth hormone
- •History of or was currently being evaluated for breast or prostate cancer
- •Prostate specific antigen above the upper limit of normal
- •Positive test for antibodies to human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or antibodies to hepatitis C virus at the Screening visit
- •Positive urine drug test at the Screening visit
- •Current treatment with oral lipase inhibitors (eg, orlistat [Xenical]), bile acid-binding resins (eg, cholestyramine [Questran], colestipol [Colestid]), fibric acid derivatives (eg, clofibrate [Atromid-X], gemfibrozil [Lopid]), and probucol (Lorelco).
- •Smokers who were unable to refrain from smoking during the confinement period required in this study
- •Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years
- •Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
- •Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose
- •Hematocrit < 35% or > 50%
- •Body mass index ≥ 31 kg/m2 -
研究组 & 干预措施
healthy men treatment arm
Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes
时间窗: 8 days
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
次要结局
- rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes(8 days)
- magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose(8 days)
- healthy men's testosterone levels in serum and plasma(8 days)