CLINICAL TRIAL: PHASE IIA, REPEAT DOSE, PHARMACOKINETIC STUDY OF ORAL TESTOSTERO

临床试验：IIA 期、重复剂量、口服睾酮的药代动力学研究

• 批准号: 7952270
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 27.64万
• 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/7952270
• 关键词: Australia; Blood; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Country; Dose; Drug Formulations; Drug Kinetics; Esters; Europe; Funding; Grant; Hormone replacement therapy; Hormones; Human body; Injection of therapeutic agent; Institution; Lipids; Marketing; Measures; Oral; Oral cavity; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Preparation; Research; Research Personnel; Resources; Source; Testosterone; Testosterone Enanthate; Time; United States; United States National Institutes of Health; 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. This is a continuation of a phase 2 study that was done at this center (LA Biomed project # 13028). 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 (broken down) by human body. This will be done by giving different doses of T-esters to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remain 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. 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, but there is no oral preparation of TE currently available. Oral TU and recently TU injections are approved in Europe, Aisa, and Australia for male hormone replacement therapy in hypogonadal men. Currently, there are no oral testosterone esters available for hypogonadal men in the United States. It is believed that the new formulations that are being used in this study will be superior to the currently available therapies in several ways. The TU preparation under study is formulated differently from the TU marketed in other countries and it is anticipated that this new TU preparation may produce blood testosterone levels that last longer.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是该中心进行的 2 期研究的延续（LA Biomed 项目#13028）。本研究的目的是确定两种新的雄性激素睾酮（也称为 T-酯）口服制剂（口服药物）如何被人体代谢（分解）。这将通过向性腺功能减退男性（缺乏雄性激素的男性）给予不同剂量的 T-酯并测量在设定时间点血液中残留的这些药物的量来完成。这些新配方含有庚酸睾酮 (TE) 或十一酸睾酮 (TU) 形式的雄性激素睾酮以及脂质（脂肪）化合物。 TE 作为注射剂用于治疗男性性腺功能减退已有 50 多年的历史，并且是美国的标准治疗方法，但目前尚无 TE 的口服制剂。口服 TU 和最近的 TU 注射剂在欧洲、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替代疗法。目前，美国还没有可供性腺机能减退男性使用的口服睾酮酯。据信，本研究中使用的新制剂将在多个方面优于目前可用的疗法。 正在研究的 TU 制剂的配方与其他国家销售的 TU 不同，预计这种新的 TU 制剂可能会产生持续更长时间的血液睾酮水平。