Conditions: Healthy
Keywords: Drug Drug Interaction Study in Normal Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).

Interventions: intervention 1: MAP0004 intervention 2: IV DHE intervention 3: Ketoconazole
Intervention descriptions: intervention 1: MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2 intervention 2: IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3 intervention 3: Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Protocol document: