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

Condition(s) targeted: Healthy Subjects

Intervention: MAP0004 (Drug); IV DHE (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Allergan

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers

AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Simbec Research Limited, Merthyr Tydfil CF48 4DR, United Kingdom

Starting date: January 2010
Last updated: December 9, 2013