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

This study has been completed.
Sponsor:
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01199965
First received: August 5, 2010
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

Compare the pharmacokinetics of Dihydroergotamine Mesylate delivered by oral inhalation (MAP0004) or intravenously (IV) (DHE 45) in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.


Condition Intervention Phase
Healthy Subjects
 Drug: MAP0004
Drug: DHE 45
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Compare the pharmacokinetics (Cmax, Tmax, AUC, half-life, Volume of Distribution, Clearance, Bioavailable Fraction) of Dihydroergotamine Mesylate delivered by oral inhalation (MAP0004) or intravenously (IV) (DHE 45) in smokers versus non-smokers. [ Time Frame: Specified time points pre through 48 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers by assessing the incidence of adverse events, changes in vital signs, ECG measurements, spirometry. [ Time Frame: 14-22 days ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DHE 45 then MAP0004
Crossover
 Drug: MAP0004
Inhalation
Drug: DHE 45
Intravenous administration
MAP0004 then DHE 45
Crossover
 Drug: MAP0004
Inhalation
Drug: DHE 45
Intravenous administration

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199965

Locations
United Kingdom
Simbec Research Limited
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
MAP Pharmaceuticals, Inc.
Investigators
Principal Investigator: S Febbraro, MD Simbec Research
  More Information

No publications provided

Responsible Party: MAP Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01199965     History of Changes
Other Study ID Numbers: MAP0004-CL-P203
Study First Received: August 5, 2010
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dihydroergotamine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013