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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01199965
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : October 22, 2013
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan

Study Description
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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 significant differences in the tolerability of MAP0004 between smokers and non-smokers.


Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: MAP0004 Drug: IV DHE Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
IV DHE then MAP0004
Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
 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
Other Name: D.H.E.45®
MAP0004 then IV DHE
Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.
 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
Other Name: D.H.E.45®


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers [ Time Frame: 48 hours ]
    The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).

  2. AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers [ Time Frame: 48 hours ]
    The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199965


Locations
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United Kingdom
Simbec Research Limited
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01199965    
Other Study ID Numbers: MAP0004-CL-P203
First Posted: September 13, 2010    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Dihydroergotamine
Vasoconstrictor Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents