Phase 2
Completed N=47
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Healthy Subjects
Source: ClinicalTrials.gov NCT01199965 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers — 1282.059; 2550.727; 60046.128; 48428.635 pg/ml
Summary
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers |
1282.059; 2550.727; 60046.128; 48428.635 | — |
| PRIMARY AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers |
3014.968; 4148.750; 11049.027; 11731.639 | — |
Eligibility Criteria
Major Inclusion Criteria:
- Able to provide written informed consent
- Male or Female subjects 18 to 45 years old
- Female subjects who are practicing adequate contraception or who are sterile
- Stable cardiac status
- Normal rhythm or arrhythmia deemed clinically insignificant on ECG
Major Exclusion Criteria:
- Contraindication to dihydroergotamine mesylate (DHE)
- Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
- History of hemiplegic or basilar migraine
- Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial
Data sourced from ClinicalTrials.gov (NCT01199965). 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.