Terminated/Withdrawn
Sponsor ID
20130246
Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects
Study Details
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.
Protocol Summary
Primary Outcome Measures
Treatment-emergent AEs
Timeframe: Up to 29 Days
Secondary Outcome Measures
Plasma PK Parameter
Timeframe: Up to 29 Days
Plasma PK Parameter
Timeframe: Up to 29 Days
Plasma PK Parameter
Timeframe: Up to 29 Days
Blood Pressure response to CPT
Timeframe: Up to 29 Days
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Status
Recruiting