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

NCT01089062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-01-09

Study results available
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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

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

Sponsors & Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Robert J Noveck, M.D., Ph.D. · Duke Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089062 on ClinicalTrials.gov