Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Condition(s) targeted: Healthy

Intervention: MAP0004 (Drug); IV DHE (Drug); Ketoconazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Allergan

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.

Official title: A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration

AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Simbec Research Limited, Merthyr Tydfil, United Kingdom

Starting date: July 2010
Last updated: December 9, 2013