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Completed

NCT Number: NCT01089062

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide a signed, executed written informed consent
  • Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
  • Female subjects who are practicing adequate contraception
  • Stable cardiac status
  • Normal hemoglobin values
  • Normal Echocardiogram
  • Normal or not clinically significant 12-lead Electrocardiogram
  • Demonstrated ability to properly use the Tempo® Inhaler
  • Subject has not donated blood in the last 56 days

Exclusion criteria

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

Treatment and study plan

MAP0004

Drug

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 Inhaler

Drug

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

IV Dihydroergotamine Mesylate (DHE)

Drug

IV DHE administered in Treatment A as per protocol

Other names: D.H.E.45®

Primary outcomes

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

    Time frame: 2 hours from time of first 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.

Secondary outcomes

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

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

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

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

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

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

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

    Time frame: 4 hours from the time of first 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.

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

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

    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.

  5. Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose

    Time frame: baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose

    The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

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

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of Intravenous Dihydroergotamine (DHE) and Orally Inhaled DHE (MAP0004) on Pulmonary Arterial Pressure and Tolerability in Healthy Adults

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 18, 2010
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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