第一阶段随机安慰剂对照、双盲研究的安全性和耐受性Bremelanotide Coadministered与乙醇在健康男性和女性参与者。

文章的细节

引用
复制到剪贴板

克莱顿啊,卢卡斯J, DeRogatis LR、约旦R

第一阶段随机安慰剂对照、双盲研究的安全性和耐受性Bremelanotide Coadministered与乙醇在健康男性和女性参与者。

其他。2017年3月,39 (3):514 - 526. - e14灯头。doi: 10.1016 / j.clinthera.2017.01.018。Epub 2017 2月9。

PubMed ID
28189361 (在PubMed
]
文摘

目的:这是一个阶段我研究来评估安全、耐受性、血流动力学和药代动力学的影响bremelanotide (BMT)与乙醇coadministered健康男性和女性参与者。方法:这是一项随机,安慰剂对照,双盲、三期,我家的交叉研究。个人会议包含/排除标准收到BMT或安慰剂有或没有乙醇连续7天在研究设施。参与者被随机分配接受1 6治疗路径;每个参与者接受单剂量的滴鼻BMT(20毫克)或安慰剂1天,4和7,有或没有口服乙醇(0.6克/公斤)在禁食状态。鼻内20毫克剂量的BMT有接触相当于~ 1到2倍剂量皮下正在评估在第三阶段的研究。生命体征、自我报告镇静评分、护理和医学观察,参与者和自发报告的不良事件评价提供了依据。体检和休息12导心电图进行第七天在基线和研究。血液和尿液样本获得临床安全性实验室测试。结果:共有24参与者注册(12人; 12 women) and completed the study. Single doses of 20 mg intranasal BMT, administered with or without 0.6 g/kg ethanol, were found to be safe and generally well tolerated with mean maximum ethanol concentrations exceeding 80 mg/dL in women. No clinically significant pharmacokinetic interactions were found between ethanol and BMT either overall or by sex. No significant drug-related hypotensive or orthostatic hypotensive effects were noted. Treatment with BMT did not result in an increased frequency of treatment-emergent adverse events, and no participants discontinued the study because of adverse events. Physical examination, electrocardiography, and laboratory tests disclosed no clinically significant changes. IMPLICATIONS: Female sexual dysfunction is a multifactorial condition with anatomic, physiologic, medical, psychological, and social components. BMT is a synthetic peptide analogue of the naturally occurring hormone alpha-melanocyte-stimulating hormone and a melanocortin receptor agonist that is being developed for the treatment of hypoactive sexual desire disorder. Its mechanism of action involves activation of endogenous melanocortin hormone pathways involved in the sexual desire and arousal response. The results of this Phase I study found that BMT and ethanol can be safely coadministered and are generally well tolerated with no reports of drug-related serious adverse events. Phase III trials of subcutaneous BMT for the treatment of hypoactive sexual desire disorder in premenopausal women are in progress. ClinicalTrials.gov identifiers NCT02338960 and NCT02333071.

beplay体育安全吗DrugBank数据引用了这篇文章

药物