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

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: MAP0004; Drug: IV DHE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199965

MAP0004-CL-P203

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

IV DHE then MAP0004

Other group

Description:

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

Treatment:

Drug: IV DHE

Drug: MAP0004

MAP0004 then IV DHE

Other group

Description:

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

Treatment:

Drug: IV DHE

Drug: MAP0004