Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Migraine
In brief
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of AMG 333 for 14 days in healthy subjects and migraine subjects. As part of the secondary objectives, the study will characterize the pharmacokinetic (PK) profile of AMG 333 after multiple oral doses in healthy subjects and migraine subjects, as well as characterize the effect of multiple doses of AMG 333 on increases in blood pressure (BP) induced by the cold pressor test (CPT) in healthy subjects.
Key facts
- Study ID
- NCT02132429
- Run by
- Amgen
- People needed
- 16
- Starts
- 2014-05-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-04-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female subjects (cohorts 1 through 5) and male and female subjects with migraines (cohort 6), who are ≥ 18 and ≤ 55 years of age at the time of screening, and have no history or evidence of clinically-relevant medical disorders as determined by the investigator in consultation with the Amgen physician.
You may not qualify if…
- History or evidence of a clinically significant disorder, condition, or disease that in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy), would pose a risk to subject safety or interfere with evaluation, procedures, or study completion.
Where it is running
- CRI Lifetree — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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