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Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

NCT01468558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-01-09

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

MAP0004

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

DRUG

IV DHE

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

DRUG

Ketoconazole

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

Sponsors & Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468558 on ClinicalTrials.gov