drugset / Trial / NCT02132429

Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects

NCT02132429 ↗

Phase 1 Terminated 16 enrolled Amgen
RandomizedFactorialQuadruple-blindPrevention

Summary

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.

Timeline

Start
2014-05
Primary completion
2014-10
Completion
2014-12

Outcome

Outcome not reported

Stopped: “The study was stopped due to an administrative decision not safety.”

Drugs

EvaluationDrugModalityDoseRoute
Subject AMG 333 Unknown — Oral

Indications