NCT05547100已完成1 期
A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
研究概览
简要总结
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥18 and <35 kg/m2
- •Subject is lactating, at least 4 weeks post-partum at dosing, and is using or willing to use an electronic breast pump for sample collection
- •Subject is willing to temporarily discontinue breastfeeding for the duration of at least 11 days post-dose
- •Subject is exclusively breastfeeding and/or pumping milk, or if not exclusively breastfeeding/pumping, has an adequate milk supply as judged by the Investigator
- •Subject's infant is able to bottle-feed
- •Subject agrees to use contraception during the study
排除标准
- •Subject has a history of lumpectomy, mastectomy, breast implants, breast augmentation, or breast reduction surgery
- •Breastfeeding is not well-established or milk supply is low as judged by the Investigator
- •Subject has mastitis or other condition that may prevent the collection of milk from one or both breasts
- •Subject is pregnant or plans to become pregnant during the study
- •Subject has had a clinically significant illness within 30 days or has had a serious infection (eg, pneumonia or septicemia) within the 3 months
- •Subject has had any vaccination within 2 weeks prior to Screening or plans to have any vaccination during the study
- •Subject has a history of known or suspected intolerance, allergy, or hypersensitivity to olanzapine or opioid antagonists, , or any component of the study drug (eg naltrexone, naloxone)
- •Subject has a history of cardiovascular disease, cerebrovascular disease, a seizure disorder, personal or family history of neuroleptic malignant syndrome, or known risk of narrow-angle glaucoma or orthostatic hypotension
- •Subject has a current or anticipated need for prescribed opioid medication during the study period
- •Subject has a positive urine drug screen for amphetamine, barbiturates, cannabinoids, cocaine, or opioids or positive cotinine test
研究组 & 干预措施
5mg OLZAPINE /10mg SAMIDORPHAN
Experimental
Open label, single dose 5mg OLZ/10 mg SAM
干预措施: LYBALVI (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
时间窗: Up to 15 days
Time to reach Cmax (tmax)
时间窗: Up to 15 days
\Maximum observed concentration (Cmax)
时间窗: Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)
时间窗: Up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: Up to 15 days
Terminal half-life (t½)
时间窗: Up to 15 days
次要结局
- Estimated relative infant dose to the weight-adjusted maternal dose (%)(Up to 15 days)
- Estimated infant dose (mg/kg)(Up to 15 days)
- Total amount of drug excreted in milk (milligrams)(Up to 15 days)
- Relative drug excreted in milk to dose percentage(Up to 15 days)
- Incidence of adverse events(Up to 15 days)
研究者
研究点 (1)
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