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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: MAP0004; Drug: IV DHE

• Registration Number: NCT01199965
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-22
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IV DHE then MAP0004	MAP0004	Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
IV DHE then MAP0004	IV DHE	Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
MAP0004 then IV DHE	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.
MAP0004 then IV DHE	MAP0004	Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.

Primary Outcome Measures

Name	Time	Method
Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers	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).
AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers	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).

Trial Locations

Locations (1)

Simbec Research Limited; 🇬🇧 Merthyr Tydfil, United Kingdom