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The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIGĀ® Rapimelt (zolmitriptan) in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PET 1: baseline, PET 2: 10 mg ZomigĀ® Rapimelt, PET 3: 5 mg ZOMIGĀ® Rapimelt, PET 4 2.5 mg ZOMIGĀ® Rapimelt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapimelt | Drug | oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5. |
|
| 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 ZOMIGĀ® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the relation between ZomigĀ® Rapimelt dose and 5-HT1B receptor occupancy | The second, third and fourth PET measurements will be performed after oral administration of ZOMIGĀ® 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Kanes | AstraZeneca | Study Director |
| Wolfgang KĆ¼hn | Quintiles AB Phase I Services | Principal Investigator |
| Brendan Smyth | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C089750 | zolmitriptan |
| C530629 | 5-methyl-8-(4-methyl-piperazin-1-yl)-4-oxo-4H-chromene-2-carboxylic acid (4-morpholin-4-yl-phenyl)amide |
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| [11C]AZ10419369 | Drug | solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIGĀ® Rapimelt |
|
| 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 |
| D009422 | Nervous System Diseases |