Two-Part, Single-Centre Pharmacokinetic Study of iOWH032 in Adult Male and Female Healthy Volunteers, and Adult Males With Cholera
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Calculation of concentration-time data
研究概览
简要总结
This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients. This is not a hypothesis-driven research study.
详细描述
This study will be conducted in two parts.
The first part (Part A) will evaluate the pharmacokinetics, safety and tolerability of iOWH032 in healthy, adult Bangladeshi volunteers.
The second part (Part B) will evaluate the pharmacokinetics, safety and tolerability of iOWH032 in adult Bangladeshi patients with cholera. While female participants will be included in Part A, only male patients will be enrolled in Part B. The rationale for excluding women in Part B is the difficulty in separating urine from stool in severely dehydrated females with rapid rates of purging. Moreover, it has been difficult to retain adult females in the hospital after improvement of their diarrhoea because of their household responsibilities, which might impact compliance in this small study. Further, no sex differences in the pharmacokinetics of iOWH032 were found in the study conducted in healthy subjects in the US, which included 42 males and females, nor have sex differnces been observed in preclinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Males / Females (Healthy)
Part A: This initial part of the study will be conducted in adult Bangladeshi healthy volunteers (4 males, 4 females) to assess the pharmacokinetics, safety, and tolerability of single doses of iOWH032. Participants will be admitted to the Clinical Trial Unit (CTU) of icddr,b (located at a 10 minute drive from the icddr,b main campus) the day prior to dosing and remain for 48 hours after dosing, unless treatment and/or follow-up of an adverse event (AE) require longer in-unit observation or treatment.
干预措施: iOWH032 (Drug)
Males (Patient)
Part B: Patients will be eligible for the study if they have clinically severe dehydration and meet all other inclusion and exclusion criteria. Upon signing consent, they will be admitted to the Research Ward of the Dhaka Hospital of icddr,b.
干预措施: iOWH032 (Drug)
结局指标
主要结局
Calculation of concentration-time data
时间窗: Day 1 through end of treatment (Day 150)
For both Part A and Part B: * pharmacokinetic parameters * adverse events (AEs) * laboratory values * physical examination and vital sign findings * summary statistics For Part B, patients with culture-proven V. cholerae O1 infection will be evaluated independently of those with a negative culture. Those who are culture negative for V. cholerae but have received iOWH032 will remain in the study and the same protocol will be followed for their management including the follow up visit.
次要结局
- Measure of Adverse Events(7 days after receipt of the single dose)