Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

• 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) or interfere with evaluation, procedures, or study completion.