CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
MAP0004 +2 moredrug
Likely dose
MAP0004 1.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01468558
NCT01468558Phase 1Completed
CompareCT.gov

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®)

Allergan·interventional·Posted Nov 9, 2011·Updated Jan 9, 2014

In Brief

A Phase 1 clinical trial evaluating MAP0004, IV DHE, and 1 other intervention for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2011
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.6 years ago

Interventions

MAP0004drug

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

IV DHEdrug

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

Ketoconazoledrug

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