CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
MAP0004 +3 moredrug
Likely dose
MAP0004 3.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01191723
NCT01191723Phase 1Completed
CompareCT.gov

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

Allergan·interventional·Posted Aug 31, 2010·Updated Jan 9, 2014

In Brief

A Phase 1 clinical trial evaluating MAP0004, Inhaler Placebo, and 2 other interventions for Healthy. Completed, enrolled 54 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2010
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.8 years ago

Interventions

MAP0004drug

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebodrug

Placebo for Inhaler administered in Treatments A and C

Moxifloxacindrug

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsuledrug

Placebo for Moxifloxacin administered in Treatment B and Treatment C