Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers

Study Identifier
MAP0004-CL-P203
CT.gov Identifier
NCT01199965
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 DHE
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18 - 45 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Major Inclusion Criteria: 1. Able to provide written informed consent 2. Male or Female subjects 18 to 45 years old 3. Female subjects who are practicing adequate contraception or who are sterile 4. Stable cardiac status 5. Normal rhythm or arrhythmia deemed clinically insignificant on ECG Major Exclusion Criteria: 1. Contraindication to dihydroergotamine mesylate (DHE) 2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5) 3. History of hemiplegic or basilar migraine 4. Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial

    Protocol Summary

    Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

    Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

    Study Locations

    Location
    Status
    Location
    Simbec Research Limited
    Merthyr Tydfil, Merthyr Tydfil, United Kingdom, CF48 4DR
    Status
    Not applicable