QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: MAP0004 (Drug); Inhaler Placebo (Drug); Moxifloxacin (Drug); Placebo Capsule (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Allergan
Summary
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered
by Oral Inhalation) with Moxifloxacin and Placebo.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 MinutesChange From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Secondary outcome: Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 MinutesChange From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 (see section 4. 4) or who
are sterile
4. No known cardiac disease
5. Normal hemoglobin values
6. 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
7. Demonstrated ability to properly use the Tempo® Inhaler
8. Subject has not donated blood in the last 56 days
Exclusion Criteria:
1. Contraindication to dihydroergotamine mesylate (DHE)
2. History of hemiplegic or basilar migraine
3. Family history of long QT syndrome
4. Participation in another investigational trial during the 30 days prior to Visit 1
Locations and Contacts
Cetero Research, Fargo, North Dakota, United States
Additional Information
Starting date: August 2010
Last updated: December 9, 2013
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