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

December 9, 2013 updated by: Allergan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • D.H.E.45®
Other: 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 Names:
  • D.H.E.45®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48 hours
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).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAP0004-CL-P203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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