NCT01089062

Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

A Randomized, Double Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of Intravenous Dihydroergotamine (DHE) and Orally Inhaled DHE (MAP0004) on Pulmonary Arterial Pressure and Tolerability in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MAP0004	1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
DRUG	IV Placebo (Saline)	IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
DRUG	Placebo Inhaler	Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
DRUG	IV Dihydroergotamine Mesylate (DHE)	IV DHE administered in Treatment A as per protocol

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2010-03-18
• Last updated: 2014-01-09
• Results posted: 2013-10-22

Locations

1 site across 1 country: United States