Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 334 Dose 1 · 1 trial · 1 indication
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.
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.
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.
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.
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.
The following measurements were performed: systolic/diastolic blood pressure, heart rate, and temperature.
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.
The clinical laboratory safety tests included: chemistry, hematology, and urinalysis.
The neurological examinations were completed as per standard of care.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | OTHER | Subjects with a body weight at Day 1 of less than weight threshold. |
| Cohort 2 | OTHER | Subjects with a body weight at Day 1 of weight threshold or more. |
| Name | Type | Description |
|---|---|---|
| AMG 334 Dose 1 | DRUG | 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 |
| AMG 334 Dose 2 | DRUG | Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2. |
| AMG 334 Dose 3 | DRUG | Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3. |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
AMG 334 Dose 1 is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and dosing in clinical trials.
AMG 334 Dose 1 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the drug's pharmacokinetics and safety in pediatric patients with migraine.
AMG 334 Dose 1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 1 trial that evaluated its pharmacokinetics in pediatric patients with migraine.
AMG 334 Dose 1 has been studied in one completed Phase 1 clinical trial, identified as NCT03499119, titled "AMG 334 20160172 Pediatric Migraine PK Study." This trial enrolled 53 participants in the United States, including children as young as 6 years old, and evaluated the drug's pharmacokinetics in migraine patients.
AMG 334 Dose 1 is a specific dose level of the drug AMG 334, which is being developed by Amgen Inc. The clinical trial NCT03499119 was designed to study the pharmacokinetics of this particular dose in pediatric patients with migraine, as part of the broader development program for AMG 334.