drugset

drugset / Trial / NCT01191723

QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

NCT01191723 ↗

Phase 1 Completed 54 enrolled Allergan MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

Timeline

Start: 2010-08
Primary completion: 2010-09
Completion: 2010-09

Publications

Kori S, Kellerman DJ, Voloshko P, Haugen G. Effects of a supratherapeutic dose of investigational orally inhaled dihydroergotamine (MAP0004) on QT interval: a randomized, double-blind, active- and placebo-controlled crossover study in healthy volunteers. Clin Ther. 2012 Sep;34(9):1920-8. doi: 10.1016/j.clinthera.2012.08.001. Epub 2012 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dihydroergotamine	Small molecule	3 mg	Inhaled
Subject	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.