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Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468558
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : October 22, 2013
Last Update Posted : January 9, 2014
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MAP0004 Drug: IV DHE Drug: Ketoconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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®)
Study Start Date : July 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 48 hours ]
    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).

  2. AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 48 hours ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468558

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Allergan Identifier: NCT01468558    
Other Study ID Numbers: MAP0004-CL-P104
First Posted: November 9, 2011    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013
Keywords provided by Allergan:
Drug Drug Interaction Study in Normal Healthy Volunteers
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Vasoconstrictor Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents