NCT01191723

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

A Randomized, Double Blind, Placebo Controlled, Three- Period Crossover Study Comparing the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo on QT Intervals in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MAP0004	3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
DRUG	Inhaler Placebo	Placebo for Inhaler administered in Treatments A and C
DRUG	Moxifloxacin	400mg encapsulated tablet administered in Treatment A as per protocol
DRUG	Placebo Capsule	Placebo for Moxifloxacin administered in Treatment B and Treatment C

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-08-31
• Last updated: 2014-01-09
• Results posted: 2013-10-22

Locations

1 site across 1 country: United States