Back to resultsDetermine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
Primary Purpose
Migraine
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Rapimelt
[11C]AZ10419369
Sponsored by
About this trial
This is an interventional basic science trial for Migraine focused on measuring Migraine, ZOMIG® Rapimelt
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt
Outcomes
Primary Outcome Measures
To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain
Secondary Outcome Measures
To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy
To describe the relation between plasma concentrations of zolmitriptan and 183C91 and 5-HT1B receptor occupancy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01085123
Brief Title
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, ZOMIG® Rapimelt
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt
Intervention Type
Drug
Intervention Name(s)
Rapimelt
Other Intervention Name(s)
ZOMIG®
Intervention Description
oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.
Intervention Type
Drug
Intervention Name(s)
[11C]AZ10419369
Intervention Description
solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Kanes
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wolfgang Kühn
Organizational Affiliation
Quintiles AB Phase I Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brendan Smyth
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
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