Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• 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; Ketoconazole

Criteria

Major Inclusion Criteria:

• Able to provide written Informed Consent

• Male or Female subjects 18 to 45 years old

• Female subjects who are practicing adequate contraception or who are sterile

• Stable cardiac status

• Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Exclusion Criteria:

• Contraindication to dihydroergotamine mesylate (DHE)

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

• History of hemiplegic or basilar migraine

• Participation in another investigational trial during the 12 weeks prior to Visit 1 or during this trial