AMG 334 20160172 Pediatric Migraine PK Study.

Study Overview
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Brief Summary
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AMG 334 20160172 Pediatric Migraine PK Study.

Detailed Description
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An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Official Title
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A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: AMG 334 Dose 1
* Drug: AMG 334 Dose 2
* Drug: AMG 334 Dose 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>Subjects with a body weight at Day 1 of less than weight threshold. | Drug: AMG 334 Dose 1<br>* Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2<br>Drug: AMG 334 Dose 3<br>* Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.<br>|
| Other: Cohort 2<br>Subjects with a body weight at Day 1 of weight threshold or more. | Drug: AMG 334 Dose 1<br>* Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2<br>Drug: AMG 334 Dose 2<br>* Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PK parameter of AMG 334 maximum observed concentration [Cmax] |  | 12 weeks for subjects completing initial treatment period | 
| Serum PK parameter of AMG 334 time to maximum concentration [tmax] |  | 12 weeks for subjects completing initial treatment period | 
| Serum PK parameter of AMG 334 area under the concentration time curve from 0 to 28 days [AUC 0-28days] |  | 12 weeks for subjects completing initial treatment period | 
| Serum PK parameter of AMG 334 trough concentration [Ctrough] |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Treatment-emergent adverse events |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Heart Rate |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Body Temperature |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Blood Pressure |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Duration and morphology of P, QRS and T waves in 12-lead electrocardiograms (ECGs) |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Standard Hematology Lab Assessments |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Standard Chemistry | Including liver function | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Standard sensory assessment of body and peripheral and central nervous systems |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension | 
| Standard motor assessment of body peripheral and central nervous systems |  | 12 weeks for subjects completing initial treatment period, 52 weeks for subjects completing the extension |