Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Study Identifier
MAP0004-CL-P104
CT.gov Identifier
NCT01468558
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
  • Ketoconazole
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 45 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Major Inclusion Criteria: * Able to provide written Informed Consent * Male or Female subjects 18 to 45 years old * Female subjects who are practicing adequate contraception or who are sterile * Stable cardiac status * Normal rhythm or arrhythmia deemed clinically insignificant on ECG 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 12 weeks prior to Visit 1 or during this trial

    Protocol Summary

    Compare the DHE pharmacokinetic profiles observed following administration of:

    1. MAP0004 (oral inhalation DHE)

    2. MAP0004 co-administered with oral Ketoconazole

    3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

    Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.

    Study Locations

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