PACTR202402687748210尚未招募1 期
IGHID 12333: Phase I study on the Pharmacokinetics of intravaginal, self-administered Artesunate vaginal pessaries among women in Kenya
niversity of North Carolina Chapel Hill Department of Obstetrics and Gynecology0 个研究点目标入组 12 人开始时间: 2024年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •Age 18 years to 65 years
- •-Negative pregnancy test at screening
- •-Weight =50 Kg at study entry*
- •-Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age)
- •-Ability and willingness to provide informed consent
- •-Plan to reside in the study location during the study period
- •-Agrees for samples without identifiers to be shipped outside of Kenya for testing
- •*Justification for weight criteria: A minimum body weight of 50Kg will meet the planned artesunate dosing of =4 mg/Kg for which excellent safety data is available.
排除标准
- •-Current pregnancy or breastfeeding status
- •-History of total hysterectomy
- •-Known allergy to Artesunate
- •-Have a medical comorbidity that in the opinion of the investigator would interfere with study participation
- •-Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days.*
- •-Male at birth
- •-Current use of efavirenz antiretroviral therapy
- •-Positive malaria antigen test at screening
- •*Based on dihydroartesunate (artesunate’s active metabolite) half-life of between 0.5-1.5 hours
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