NCT01468558

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MAP0004	MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2
DRUG	IV DHE	IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3
DRUG	Ketoconazole	Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2011-11-09
• Last updated: 2014-01-09
• Results posted: 2013-10-22

Locations

1 site across 1 country: United Kingdom