NCT01199965

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

An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	MAP0004	1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol
DRUG	IV DHE	IV DHE administered at Visit 2 or 3 as per protocol

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-09-13
• Last updated: 2014-01-09
• Results posted: 2013-10-22

Locations

1 site across 1 country: United Kingdom