Phase 1
Completed N=54
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Healthy
Source: ClinicalTrials.gov NCT01191723 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes — 408.8; 409.6; -4.7; -4.6 milliseconds
Summary
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes |
408.8; 409.6; -4.7; -4.6 | — |
| PRIMARY Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours |
408.8; 409.6; 408.6; -2.3; -5.1; 9.0 | — |
| SECONDARY Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes |
406.8; 407.7; -5.0; -4.7 | — |
| SECONDARY Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours |
406.8; 407.7; 407.0; -1.8; -3.9; 8.5 | — |
| SECONDARY Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours |
64.1; 64.6; 63.8; 1.0; -0.2; 2.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01191723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.