Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

Allergan24 enrolled

Overview

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

MAP0004DRUG

1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol

IV Placebo (Saline)DRUG

IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol

Placebo InhalerDRUG

Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to provide a signed, executed written informed consent 2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old 3. Female subjects who are practicing adequate contraception 4. Stable cardiac status 5. Normal hemoglobin values 6. Normal Echocardiogram 7. Normal or not clinically significant 12-lead Electrocardiogram 8. Demonstrated ability to properly use the Tempo® Inhaler 9. Subject has not donated blood in the last 56 days Exclusion Criteria: 1. Contraindication to dihydroergotamine mesylate (DHE) 2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 3. History of hemiplegic or basilar migraine 4. Participation in another investigational trial during the 30 days prior to Visit 1

Locations (1)

Duke Clinical Research Unit

Durham, North Carolina, United States

Outcomes

Primary Outcomes

AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose

AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.

Time frame: 2 hours from time of first dose

Secondary Outcomes

Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose

Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.

Time frame: baseline and 2 hours from the time of first dose

Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose

Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.

Time frame: baseline and 2 hours from the time of first dose

AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose

AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.

Time frame: 4 hours from the time of first dose

Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods

Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.

Time frame: baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose

Data from ClinicalTrials.gov

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