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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 Minutes

Change 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 Minutes

Change 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

Page last updated: August 23, 2015

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