PHASE IIA, PILOT, PHARMACOKINETIC STUDY OF ORAL TESTOSTERONE ESTER FORMULATIO

口服睾酮酯制剂的 IIA 期试验药代动力学研究

• 批准号: 7952260
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 21.97万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952260
• 关键词: Adverse effects; Asia; Australia; Blood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Country; Dose; Drug Formulations; Drug Kinetics; Esters; Europe; Funding; Grant; Hormones; Human body; Injection of therapeutic agent; Institution; Intestines; Lipids; Liver; Marketing; Measures; Oral; Oral cavity; Pharmaceutical Preparations; Phase; Preparation; Research; Research Personnel; Resources; Source; Testosterone; Testosterone Enanthate; Time; United States; United States National Institutes of Health; absorption; male; men; oral form testosterone; standard of care

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine how two new oral formulations (medications to be taken by mouth) of male hormone Testosterone (also called T-esters) are metabolized by human body. This will be done by giving different doses of these T-esters to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in the blood at set time points. These new formulations contain male hormone testosterone in the form of Testosterone Enanthate (TE) or Testosterone Undecanoate (TU) combined with a lipid (fatty) compound. The lipid part of these medications makes absorption of the testosterone portion easier and more efficient by being largely absorbed in the intestine instead of first going to and being broken down by the liver. TE has been used as an injection for the treatment of hypogonadal men for over 50 years and is the standard of care in the United States. There is no oral preparation of TE available. Oral TU and recently TU injections have been approved in Europe, Asia, and Australia for male hormone treatment of hypogonadal men. The TI preparation under study is formulated differently from the TU marketed in other countries. It is anticipated that this new TU preparation may last longer. These esters, when injected or taken by mouth, are broken down to testosterone portion and the ester portion. The ester portion is metabolized without any action in the body (i.e. cause no side effects).

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定两种新的口服制剂（口服药物）的男性激素Tehran（也称为T-酯）是如何被人体代谢的。这将通过给予 不同剂量的这些T-酯性腺功能减退的男子（男子缺乏男性激素） 并测量在设定的时间点有多少这些药物残留在血液中。 这些新的配方含有男性激素睾酮的形式，特戊庚酸酯（TE）或特戊十一酸酯（TU）结合脂质（脂肪）化合物。 这些药物的脂质部分使睾酮部分的吸收更容易和更有效，主要是在肠道中吸收，而不是首先进入肝脏并被肝脏分解。 TE已被用作治疗性腺功能减退男性的注射剂超过50年，并且是美国的标准护理。没有TE的口服制剂可用。口服TU和最近TU注射剂已在欧洲、亚洲和澳大利亚被批准用于性腺功能减退男性的雄性激素治疗。正在研究的TI制剂的配方与其他国家销售的TU不同。预计这一新的TU准备工作可能会持续更长时间。 这些酯，当注射或口服，被分解成睾丸激素部分 和酯部分。 酯部分 在体内代谢而不起任何作用（即不会引起副作用）。