Status:
COMPLETED
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Lead Sponsor:
Allergan
Collaborating Sponsors:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01191723
Start Date
August 1 2010
End Date
September 1 2010
Last Update
January 9 2014
Active Locations (1)
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1
Cetero Research
Fargo, North Dakota, United States