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

Study Overview
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Brief Summary
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The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rapimelt
* Drug: [11C]AZ10419369


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt | Drug: Rapimelt<br>* oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.<br>* Other names: ZOMIG®;Drug: [11C]AZ10419369<br>* solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy |  | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, ZOMIG® Rapimelt