MedTrace Logo

Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers

NCT01199965 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2014-01-09

Study results available
· View outcomes & findings →

Summary

Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

Conditions

  • Healthy Subjects

Interventions

DRUG

MAP0004

1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol

DRUG

IV DHE

IV DHE administered at Visit 2 or 3 as per protocol

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01199965 on ClinicalTrials.gov