Pharmacokinetics of Multiple Dose Methadone in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- PK Parameters after multiple doses of enteral methadone
研究概览
简要总结
The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. While this drug is used extensively in infants and children, it has not been extensively studied in this population.
Physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. Physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. During this research study, the study team will collect information about how this drug is processed in infants and children.
详细描述
A total of approximately 24 to 36 infants and children will participate in this study. This study will be done at five medical centers in the United States.
Treatment will be prescribed by the infant or child's doctor and not by the study team.
Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Information collected from each subject's routine medical care will include:
- Participant gender, date of birth, race and ethnicity
- Pertinent medical history
- Laboratory results (blood count and chemistries) from routine testing ordered by the infant or child's regular doctor
- Medications of interest the child was given within the 72 hours prior to first dose of methadone administered after consent
- Time and dose of methadone administered to the child up to 14 days prior to enrollment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 91 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>90 days - < 18 years of age at the time of first dose of study drug
- •Receiving enteral methadone as standard of care
- •Signed informed consent/HIPAA documents by the parent/legal guardian and assent (if applicable)
排除标准
- •Previous participation in the study
- •Subject is receiving ECLS (Extracorporeal Life Support)
- •< 36 weeks gestational age at birth for children <1 year of age at time of enrollment
- •Any other condition or chronic illness that in the opinion of the Principal
- •Investigator makes participation unadvised or unsafe
研究组 & 干预措施
Cohort 3
6 years to < 18 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile.
干预措施: Methadone (Drug)
Cohort 1
> or = 90 days to < 2 years on enteral methadone. Dose schedule is per routine medical care.
干预措施: Methadone (Drug)
Cohort 2
2 years to < 6 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile.
干预措施: Methadone (Drug)
结局指标
主要结局
PK Parameters after multiple doses of enteral methadone
时间窗: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
* Apparent oral clearance * Apparent oral volume of distribution * Area under the curve * Absorption rate constant
次要结局
- PK of methadone's primary metabolite EDDP(Maximum of 7 PK samples based on dosing schedule collected over a 5 day period)
- PK of R- and S-enantiomers of methadone(Maximum of 7 PK samples based on dosing schedule collectes over a 5 day period)
- Correlation between plasma and DBS samples(Maximum of 7 PK samples based on dosing schedule collected over a 5 day period)
- Adverse events(Study days 1-5 and observational days 6-10)
- Correlation between plasma and scavenge samples(Maximum of 7 PK samples based on dosing schedule collected over a 5 day period)
- Influence of CYP3A4 and CYP3B6 genetic polymorphisms on methadone PK(Maximum of 7 PK samples based on dosing schedule collected over a 5 day period)
- Methadone pharmacodynamics using the WAT-1(Maximum of 7 PK samples based on dosing schedule collected over a 5 day period)
研究者
Kevin Watt
Assistant Professor of Pediatrics
Duke University