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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014