Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allergan
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Treatments: Dihydroergotamine

Criteria

Inclusion Criteria:

1. Able to provide a signed, executed written informed consent

2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old

3. Female subjects who are practicing adequate contraception

4. Stable cardiac status

5. Normal hemoglobin values

6. Normal Echocardiogram

7. Normal or not clinically significant 12-lead Electrocardiogram

8. Demonstrated ability to properly use the Tempo® Inhaler

9. Subject has not donated blood in the last 56 days

Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)

2. Use of any excluded concomitant medications within the 10 days prior to Visit 1

3. History of hemiplegic or basilar migraine

4. Participation in another investigational trial during the 30 days prior to Visit 1