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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01191723

Run by

Allergan

People needed

54

Starts

2010-08-01

Expected to finish

2010-09-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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