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Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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.

Clinical Details

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.


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

Locations and Contacts

Simbec Research Limited, Merthyr Tydfil, United Kingdom
Additional Information

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

Page last updated: August 23, 2015

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