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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199965
• Other study ID #: MAP0004-CL-P203
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 5, 2010
• Last updated: December 9, 2013
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• MAP0004
1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol
• IV DHE
IV DHE administered at Visit 2 or 3 as per protocol

Locations

Country	Name	City	State
United Kingdom	Simbec Research Limited	Merthyr Tydfil

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers	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	No
Primary	AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers	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	No