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Completed

NCT Number: NCT01191723

QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

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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

Cetero Research

Fargo, North Dakota, 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 (see section 4.4) or who are sterile
  • No known cardiac disease
  • Normal hemoglobin values
  • Normal or not clinically significant 12-lead Electrocardiogram
  • Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)
  • Subjects with QTcF interval duration <430 msec for males and <450 msec for females obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position
  • 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)
  • History of hemiplegic or basilar migraine
  • Family history of long QT syndrome
  • Participation in another investigational trial during the 30 days prior to Visit 1

Treatment and study plan

MAP0004

Drug

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Drug

Placebo for Inhaler administered in Treatments A and C

moxifloxacin

Drug

400mg encapsulated tablet administered in Treatment A as per protocol

Other names: Avelox®

Placebo capsule

Drug

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Primary outcomes

  1. Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes

    Time frame: baseline and 30 minutes

    The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

  2. Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours

    Time frame: baseline and 2 hours

    The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

Secondary outcomes

  1. Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes

    Time frame: baseline and 30 minutes

    The Fridericia corrected QT interval(QTcF) 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.

  2. Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours

    Time frame: baseline and 2 hours

    The Fridericia corrected QT interval(QTcF) 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.

  3. Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours

    Time frame: baseline, 30 minutes, and 2 hours

    The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.

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 Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo on QT Intervals in Healthy Adults

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 31, 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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