Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Phase 1 Completed 24 enrolled Allergan MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-07
Primary completion: 2010-08
Completion: 2010-08

Publications

Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dihydroergotamine	Small molecule	1 mg	Inhaled
Subject	Ketoconazole	Small molecule	400 mg	Oral

Indications

No indication recorded.