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

Purpose

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous infusion on Pulmonary Arterial Pressure as determined by echocardiography.
Assess the Pharmacokinetics of DHE and its metabolites in relation to the parent component.
Compare the acute effects and tolerability of DHE delivered by Oral Inhalation (MAP0004) versus by intravenous infusion on cardiac function other than pulmonary arterial pressure as determined by echocardiography.
Compare the pharmacodynamics and pharmacokinetics of DHE delivered by Oral Inhalation (MAP0004) to a single dose of DHE Delivered Intravenously (IV DHE)

Condition	Intervention	Phase
Healthy	Drug: MAP0004 Drug: IV Placebo Drug: Placebo Inhaler Drug: DHE 45	Phase 1

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

Resource links provided by NLM:

Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate

U.S. FDA Resources

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:

Absolute changes in pulmonary arterial systolic pressure (PASP) over time post 1st dose (to be evaluated using AUC 0-2 hrs) [ Time Frame: Within 30 min pre dose and at 3, 5, 7, 10, 12, 15, 20, 25, 30, 60, 90 and 120 min post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	March 2010
Study Completion Date:	December 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Inhaler Placebo Inhaler	Drug: Placebo Inhaler Inhaled placebo
Active Comparator: DHE 45 IV DHE	Drug: DHE 45 IV DHE
Placebo Comparator: IV Placebo IV Placebo	Drug: IV Placebo IV Placebo
Experimental: Drug: MAP0004 Orally Inhaled DHE	Drug: MAP0004 Orally inhaled DHE

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Able to provide a signed, executed written informed consent
Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
Female subjects who are practicing adequate contraception
Stable cardiac status
Normal hemoglobin values
Normal Echocardiogram
Normal or not clinically significant 12-lead Electrocardiogram
Demonstrated ability to properly use the Tempo® Inhaler
Subject has not donated blood in the last 56 days

Exclusion Criteria:

Contraindication to dihydroergotamine mesylate (DHE)
Use of any excluded concomitant medications within the 10 days prior to Visit 1
History of hemiplegic or basilar migraine
Participation in another investigational trial during the 30 days prior to Visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089062

Locations

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

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Robert J Noveck, M.D., Ph.D.

Duke Clinical Research Unit

More Information

No publications provided

Responsible Party:	Medical Affairs at MAP Pharmaceuticals, MAP Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01089062 History of Changes
Other Study ID Numbers:	MAP0004-CL-P102
Study First Received:	March 17, 2010
Last Updated:	February 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

Healthy volunteers

Additional relevant MeSH terms:

Dihydroergotamine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013