NCT03962062已完成1 期
An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
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
- 36
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
研究概览
简要总结
The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over. The secondary purpose is to evaluate the safety and pharmacokinetics of a single dose of moxidectin in children and adolescents aged 4 to 17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4 to 17 years, inclusive:
- •Cohort I: 12 to 17 years;
- •Cohort II: 8 to 11 years;
- •Cohort III: 4 to 7 years;
- •Live in a region designated by the World Health Organization (WHO) as endemic for O. volvulus infection (World Health Organization, 2019). Specifically, participants will be recruited from the Kpassa sub-district of the Nkwanta North district.The specific communities will include Wii, Jagri-Do, and Azua where mass drug administration with ivermectin for onchocerciasis commenced in October 2017;
- •Willing and able to remain at the study clinic from Screening up to Day 7;
- •Provision of parental or guardian written informed consent and assent / lack of expression of 'deliberate objection' (as appropriate for age);
- •Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Baseline (pre-treatment on Day 0) until approximately 6 months after treatment with study drug.
排除标准
- •History of serious medical or psychiatric condition which, in the opinion of the investigator, would put the subject at increased risk by participating in the study or jeopardize study outcomes;
- •Known or suspected concurrent clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunological disorders or malignancy, congenital heart disease, chronic lung disease;
- •Has received an investigational product within 28 days or 5 half-lives of Baseline, whichever is longer;
- •Has received ivermectin or any other anti-helminthic treatments within 28 days of Baseline;
- •Has received a vaccination within 7 days of Baseline;
- •Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin;
- •Poor venous access;
- •Unable to swallow tablets (flat oval, 8.0 millimeters (mm) x 4.5 mm x 3.0 mm);
- •Cohort I (12 to 17 years): < 30 kg;
- •Cohort II (8 to 11 years): < 18 kg;
- •Cohort III (4 to 7 years): < 12 kg;
- •Clinically relevant laboratory abnormalities at Screening, including:
- •Hemoglobin < 9.5 grams per deciliter (g/dL);
- •Neutrophil (granulocyte) count < 1.5 x 109/L;
- •Platelet count < 110 x 109/L;
- •Alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (ULN);
- •Total bilirubin > 1.5 times ULN;
- •Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) positive;
- •Known or suspected malaria or other ongoing viral, bacterial, or plasmodium infection at Screening and/or Baseline;
- •Loa loa co-infection;
- •Unwilling, unlikely or unable to comply with all protocol specified assessments;
- •For females of child bearing potential, pregnant or breastfeeding, or planning to become pregnant;
- •Previous enrolment in this study;
- •Is a sibling of another child already enrolled in this study.
研究组 & 干预措施
Cohort 1: 12-17 years
Experimental
Moxidectin 8mg per oral, single dose
干预措施: Moxidectin (Drug)
Cohort 2: 8-11 years
Experimental
Moxidectin 8mg (or lower dose) per oral, single dose
干预措施: Moxidectin (Drug)
Cohort 3: 4-7 years
Experimental
Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2
干预措施: Moxidectin (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
时间窗: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
次要结局
- Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin(Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12.)
- Maximum Observed Plasma Concentrations (Cmax) of Moxidectin(Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.)
- Incidence and Severity of Adverse Events.(Day 0 to Week 24 inclusive.)
研究者
研究点 (1)
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