CLINICAL TRIAL: A MULTIPLE DOSE, PHARMACOKINETIC STUDY

临床试验：多剂量药代动力学研究

• 批准号: 8174500
• 负责人: CHRISTINA C. WANG
• 金额: $ 1.84万
• 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: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174500
• 关键词: Blood; Circadian Rhythms; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Formulations; Drug Kinetics; Funding; Gel; Grant; Hormones; Human body; Institution; Marketing; Measures; Nose; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Research; Research Personnel; Resources; Risk; Serum; Skin; Source; Testosterone; Time; United States; United States National Institutes of Health; Variant; innovation; male; men

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 a new intranasal (applied inside the nose) gel formulation of male hormone Testosterone called Nasobol¿ is metabolized by human body. This will be done by giving different doses of Nasobol¿ to hypogonadal men (men deficient in male hormone) and measuring how much of these medications remains in blood at set time points. This study will have two groups: hypogonadal men receiving study medication and healthy men not receiving study medication. Blood levels of testosterone in the hypogonadal men will be compared to those in the healthy men. Testosterone levels in healthy men follow a diurnal pattern in which testosterone is high in the morning and gradually declines reaching lowest levels in the early evening. Current marketed formulations of testosterone provide constant serum levels that do not mimic this variation. Nasobol¿ is an innovative pharmaceutical formulation of testosterone for nasal administration that has the potential advantages of ease of use, the possibility to mimic diurnal variation of serum testosterone levels, no risk of transfer to other people like in the testosterone applied on the skin. Currently, there is no available intranasal testosterone gel available for hypogonadal men in the United States.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 这项研究的目的是确定雄性睾丸激素的新鼻内（鼻子内）如何被人体代谢。这将通过将不同剂量的纳索伯尔剂量给性纳索伯（Nasobol）（男性缺乏雄性马酮），并测量在设定的时间点中剩下多少这些药物。这项研究将有两组：肾上腺大部分男性接受学习药物和不接受学习药物的健康男性。性睾丸激素的血液水平将与健康男性中的睾丸激素水平进行比较。 健康男性中的睾丸激素水平遵循昼夜模式，在这种模式下，睾丸激素在早晨较高，并且逐渐下降到早期的水平最低。睾丸激素的当前销售公式提供了恒定的血清水平，这些水平不会模仿这种变化。纳索博尔是一种用于鼻施用的睾丸激素的创新药物公式，具有易用性的潜在优势，是模仿血清睾丸激素水平的根本性变化的可能性，没有转移给其他人的风险，例如在皮肤上应用的睾丸激素。目前，美国的鼻内睾丸激素凝胶尚无可用于美国的性低肿瘤男性。