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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMG 333 | Unknown | — | Oral |