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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allergan
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Treatments: Dihydroergotamine; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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