Status:
COMPLETED
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Lead Sponsor:
Allergan
Collaborating Sponsors:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief 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 si...
Eligibility Criteria
Inclusion
- Major
- 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
- Major
Exclusion
- Contraindication to dihydroergotamine mesylate (DHE)
- Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
- History of hemiplegic or basilar migraine
- Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01199965
Start Date
January 1 2010
End Date
April 1 2010
Last Update
January 9 2014
Active Locations (1)
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1
Simbec Research Limited
Merthyr Tydfil, Merthyr Tydfil, United Kingdom, CF48 4DR