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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: MAP0004 (Drug); IV Placebo (Saline) (Drug); Placebo Inhaler (Drug); IV Dihydroergotamine Mesylate (DHE) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Robert J Noveck, M.D., Ph.D., Principal Investigator, Affiliation: Duke Clinical Research Unit


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose

Secondary outcome:

Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose

Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose

AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose

Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods

Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


Inclusion Criteria: 1. Able to provide a signed, executed written informed consent 2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old 3. Female subjects who are practicing adequate contraception 4. Stable cardiac status 5. Normal hemoglobin values 6. Normal Echocardiogram 7. Normal or not clinically significant 12-lead Electrocardiogram 8. Demonstrated ability to properly use the Tempo® Inhaler 9. Subject has not donated blood in the last 56 days Exclusion Criteria: 1. Contraindication to dihydroergotamine mesylate (DHE) 2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 3. History of hemiplegic or basilar migraine 4. Participation in another investigational trial during the 30 days prior to Visit 1

Locations and Contacts

Duke Clinical Research Unit, Durham, North Carolina 27710, United States
Additional Information

Starting date: March 2010
Last updated: December 9, 2013

Page last updated: August 23, 2015

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