Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All subjects

Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).

Group Type OTHER

MAP0004

Intervention Type DRUG

MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2

IV DHE

Intervention Type DRUG

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

Ketoconazole

Intervention Type DRUG

Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Interventions

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MAP0004

MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2

Intervention Type DRUG

IV DHE

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

Intervention Type DRUG

Ketoconazole

Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Intervention Type DRUG

Other Intervention Names

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D.H.E.45® Nizoral®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes