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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

MAP0004

Intervention Type DRUG

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

IV DHE

Intervention Type DRUG

IV DHE administered at Visit 2 or 3 as per protocol

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

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

IV DHE

Intervention Type DRUG

IV DHE administered at Visit 2 or 3 as per protocol

Interventions

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MAP0004

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

Intervention Type DRUG

IV DHE

IV DHE administered at Visit 2 or 3 as per protocol

Intervention Type DRUG

Other Intervention Names

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D.H.E.45®

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes