A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 26
- 主要终点
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
研究概览
简要总结
The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it.
This study is seeking participants who:
- Are children aged between 6 and less than 12 years old
- Have had migraine for at least 6 months.
- Weigh more than 15 kilograms
All participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs.
The study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine.
Participants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 6 years to less than 12 years.
- •Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- •Weight >15 kg at the Screening Visit
排除标准
- •Evidence or history of clinically significant disease.
- •Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- •Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- •Conditions that may affect the administration or absorption of the nasal product
- •Any psychiatric condition that is uncontrolled and/or untreated, including:
- •Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
- •Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
- •Serum Total bilirubin >1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) >2 × ULN
- •Abnormal ECG (Electrocardiogram) at screening visit
研究组 & 干预措施
Zavegepant
Experimental medicine under study
干预措施: Zavegepant (Drug)
结局指标
主要结局
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Tmax is defined as the time to reach maximum observed plasma concentration
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
Area Under the Curve From Time Zero to infinity.
时间窗: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
AUC (0 - inf) is defined as area under the concentration-time curve from time 0 to infinity.
次要结局
- Number of participants with clinically significant abnormal laboratory findings(Assessed from screening up to 6 days after administration of study drug)
- Number of participants with clinically significant abnormal vital signs(Assessed from screening up to 6 days after administration of study drug)
- Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs)(TEAE is reported from informed consent up to 28 days after administration of study drug.)
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)(Assessed from screening up to 6 days after administration of study drug)