Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Major Inclusion Criteria:

1. Able to provide written informed consent

2. Male or Female subjects 18 to 45 years old

3. Female subjects who are practicing adequate contraception or who are sterile

4. Stable cardiac status

5. Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Major Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)

2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)

3. History of hemiplegic or basilar migraine

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