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

Phase 2CompletedNCT01199965

Allergan47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

MAP0004DRUG

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

IV DHEDRUG

IV DHE administered at Visit 2 or 3 as per protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Simbec Research Limited

Merthyr Tydfil, Merthyr Tydfil, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 48 hours

Data from ClinicalTrials.gov

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