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

Study Identifier
MAP0004-CL-P102
CT.gov Identifier
NCT01089062
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • MAP0004
  • IV Placebo (Saline)
  • Placebo Inhaler
  • IV Dihydroergotamine Mesylate (DHE)
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 45 Years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Duke Clinical Research Unit
    Durham, North Carolina, United States, 27710
    Status
    Not applicable