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

NCT01199965 | Completed Phase 1 Results

• 1 other identifier: MAP0004-CL-P203
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

IV DHE then MAP0004

OTHER

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; Drug: IV DHE

MAP0004 then IV DHE

OTHER

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; Drug: IV DHE

Interventions

MAP0004 DRUG

1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol

IV DHE then MAP0004; MAP0004 then IV DHE

IV DHE DRUG

IV DHE administered at Visit 2 or 3 as per protocol

Also known as: D.H.E.45®

IV DHE then MAP0004; MAP0004 then IV DHE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide written informed consent
• Male or Female subjects 18 to 45 years old
• Female subjects who are practicing adequate contraception or who are sterile
• Stable cardiac status
• Normal rhythm or arrhythmia deemed clinically insignificant on ECG

You may not qualify if:

• Contraindication to dihydroergotamine mesylate (DHE)
• Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
• History of hemiplegic or basilar migraine
• Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial

Sponsors & Collaborators

• Allergan: lead
• MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan: collaborator

Study Sites (1)

Simbec Research Limited

Merthyr Tydfil, Merthyr Tydfil, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

Dihydroergotamine

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: VP, Scientific Affairs
• Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

dkellerman@mappharma.com

650-386-3100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: September 13, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 9, 2014
• Results First Posted: October 22, 2013

Record last verified: 2013-12

Locations

GB (1)