Conditions: Healthy
Keywords: Healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4. arm 2: The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4. arm 3: The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4. arm 4: The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4. arm 5: The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4. arm 6: The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.

Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.

Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.

Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.

Interventions: intervention 1: MAP0004 intervention 2: IV Placebo (Saline) intervention 3: Placebo Inhaler intervention 4: IV Dihydroergotamine Mesylate (DHE)
Intervention descriptions: intervention 1: 1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol intervention 2: IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol intervention 3: Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol. intervention 4: IV DHE administered in Treatment A as per protocol

Protocol document: