Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01468558
First received: October 28, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: MAP0004
Drug: IV DHE
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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®)

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).

  • AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).


Enrollment: 24
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
Other Name: D.H.E.45®
Drug: Ketoconazole
Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
Other Name: Nizoral®

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468558

Locations
United Kingdom
Simbec Research Limited
Merthyr Tydfil, United Kingdom
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01468558     History of Changes
Other Study ID Numbers: MAP0004-CL-P104
Study First Received: October 28, 2011
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Allergan:
Drug Drug Interaction Study in Normal Healthy Volunteers

Additional relevant MeSH terms:
Dihydroergotamine
Ketoconazole
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 22, 2014