Phase 1
Completed N=24
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Healthy
Source: ClinicalTrials.gov NCT01468558 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration — 2582.507; 2495.100; 27771.234 pg/ml
Summary
Compare the DHE pharmacokinetic profiles observed following administration of:
1. MAP0004 (oral inhalation DHE)
2. MAP0004 co-administered with oral Ketoconazole
3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)
Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration |
2582.507; 2495.100; 27771.234 | — |
| PRIMARY AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration |
3484.725; 4070.611; 9229.171 | — |
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
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 12 weeks prior to Visit 1 or during this trial
Data sourced from ClinicalTrials.gov (NCT01468558). 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.