Terminated/Withdrawn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

Sponsor ID
20130246
Clinicaltrials.gov ID
NCT02132429
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 333
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
48
Additional Study Details

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
Status
Contact Us
Location
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Status
Recruiting