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Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085123
First Posted: March 11, 2010
Last Update Posted: November 3, 2010
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.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.

Condition Intervention Phase
Migraine Drug: Rapimelt Drug: [11C]AZ10419369 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Positron Emission Tomography (PET) Study With [11C]AZ10419369 to Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain [ Time Frame: The first PET measurement will serve as a baseline assessment. The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). ]

Secondary Outcome Measures:
  • To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy [ Time Frame: The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). Imaging data analysis will be performed after each PET measurement ]
  • To describe the relation between plasma concentrations of zolmitriptan and 183C91 and 5-HT1B receptor occupancy [ Time Frame: For each of 3 visits venous blood for zolmitriptan and 183C91 PK analyses taken before drug administration and at 3 time points during PET examination: start, middle and end, ie, at 0, +30 and + 63 minutes relative to injection of the radioli ]

Enrollment: 10
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt
Drug: Rapimelt
oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.
Other Name: ZOMIG®
Drug: [11C]AZ10419369
solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index between ≥19 and ≤30 kg/m2.

Exclusion Criteria:

  • A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease
  • Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first PET
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01085123


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stephen Kanes AstraZeneca
Principal Investigator: Wolfgang Kühn Quintiles AB Phase I Services
Study Chair: Brendan Smyth AstraZeneca
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01085123     History of Changes
Other Study ID Numbers: D1220C00005
First Submitted: March 10, 2010
First Posted: March 11, 2010
Last Update Posted: November 3, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Migraine
ZOMIG® Rapimelt

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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