A Phase I, Randomized, Open-label, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Overview
- Phase
- Phase 1
- Intervention
- AMG 334 Dose 1
- Conditions
- Migraine
- Sponsor
- Amgen
- Enrollment
- 53
- Locations
- 14
- Primary Endpoint
- Time to Maximum Concentration (Tmax) of Erenumab
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
AMG 334 20160172 Pediatric Migraine PK Study.
Detailed Description
An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
Intervention: AMG 334 Dose 1
Cohort 1
Subjects with a body weight at Day 1 of less than weight threshold.
Intervention: AMG 334 Dose 3
Cohort 2
Subjects with a body weight at Day 1 of weight threshold or more.
Intervention: AMG 334 Dose 1
Cohort 2
Subjects with a body weight at Day 1 of weight threshold or more.
Intervention: AMG 334 Dose 2
Outcomes
Primary Outcomes
Time to Maximum Concentration (Tmax) of Erenumab
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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.