Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01199965
First received: August 5, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Healthy Subjects
Drug: MAP0004
Drug: IV DHE
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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).

  • AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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).


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
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®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01199965     History of Changes
Other Study ID Numbers: MAP0004-CL-P203
Study First Received: August 5, 2010
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 25, 2014