Phase 1
Completed N=24
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Healthy
Source: ClinicalTrials.gov NCT01089062 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose — 2794.93; 2580.06; 2497.71 mmHg*min
Summary
Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose |
2794.93; 2580.06; 2497.71 | — |
| SECONDARY Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose |
4.2; 0.0; 0.0 | — |
| SECONDARY Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose |
22.8; 19.2; 21.2; 7.8; 6.1; 4.0 | — |
| SECONDARY AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose |
5700.11; 5336.38; 4907.03 | — |
| SECONDARY Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods |
112.5; 113.3; 113.2; 10.4; 4.7; 0.4 | — |
| SECONDARY Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose |
403.9; 402.3; 399.9; -5.8; -0.8; 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
- Stable cardiac status
- Normal hemoglobin values
- Normal Echocardiogram
- Normal or not clinically significant 12-lead Electrocardiogram
- 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)
- Use of any excluded concomitant medications within the 10 days prior to Visit 1
- History of hemiplegic or basilar migraine
- Participation in another investigational trial during the 30 days prior to Visit 1
Data sourced from ClinicalTrials.gov (NCT01089062). 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.