Conditions: Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 47
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3. arm 2: Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.

Interventions: intervention 1: MAP0004 intervention 2: IV DHE
Intervention descriptions: intervention 1: 1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol intervention 2: IV DHE administered at Visit 2 or 3 as per protocol

Protocol document: