A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 53
- 试验地点
- 14
- 主要终点
- Time to Maximum Concentration (Tmax) of Erenumab
研究概览
简要总结
AMG 334 20160172 Pediatric Migraine PK Study.
详细描述
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •Male and female children and adolescents ≥ 6 and <18 years of age upon entry into screening
- •Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening
- •Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period
排除标准
- •Currently receiving treatment in another investigational device or drug study
- •History of migraine with brainstem aura or hemiplegic migraine headache
- •Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent
- •Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years.
- •Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.
研究组 & 干预措施
Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
干预措施: AMG 334 Dose 1 (Drug)
Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
干预措施: AMG 334 Dose 3 (Drug)
Cohort 2
Subjects with a body weight at Day 1 of weight threshold or more.
干预措施: AMG 334 Dose 1 (Drug)
Cohort 2
Subjects with a body weight at Day 1 of weight threshold or more.
干预措施: AMG 334 Dose 2 (Drug)
结局指标
主要结局
Time to Maximum Concentration (Tmax) of Erenumab
时间窗: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for pharmacokinetic (PK) testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. Noncompartmental analysis (NCA) was performed for erenumab PK parameter estimation.
Maximum Observed Concentration (Cmax) of Erenumab
时间窗: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Trough Concentration (Ctrough) of Erenumab
时间窗: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Area Under the Concentration Time Curve From 0 to 28 Days (AUC0-28day) of Erenumab
时间窗: First dose: Days 1 (pre-dose), 8, 15, and 29 (pre-dose); third dose: Days 57 (pre-dose), 64, 71, and 85
Blood samples for PK testing were collected for the measurement of PK concentrations. Serum erenumab concentrations were determined using a validated assay. NCA was performed for erenumab PK parameter estimation.
Number of Participants With Clinically Significant Changes in Vital Signs Measurements
时间窗: Up to Week 52 + 16-week safety follow-up
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Measurements
时间窗: Up to Week 52
Clinically significant changes in ECG was defined as incidence of abnormal ECG diagnosis based on 12-lead ECG including heart rate, QRS, QTc and PR intervals.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Safety Tests
时间窗: Up to Week 52 + 16-week safety follow-up
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
Number of Participants With Clinically Significant Changes in Neurological Assessments
时间窗: Up to Week 52 + 16-week safety follow-up
The neurological examinations were completed as per standard of care.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to Week 52 + 16-week safety follow-up
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant. A TEAE was defined as an AE starting on or after first dose of investigational product. The event did not necessarily have a causal relationship with study treatment.
次要结局
未报告次要终点