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Rapimelt

Phase 1

Migraine | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Nov 3, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01085123Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male VolunteersPHASE1 COMPLETED 10 — — May 1, 2010Oct 1, 2010Nov 3, 20101 Sweden
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt
Interventions
NameTypeDescription
RapimeltDRUGoral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.
[11C]AZ10419369DRUGsolution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:Sweden
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Competitive Landscape -Migraine 32 trials
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AbbVie, Inc.ABBV15PHASE3Atogepant, Topiramate, Ubrogepant, MEDI0618
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Eli Lilly and CompanyLLY2PHASE3Galcanezumab
Amgen Inc.AMGN2PHASE3Erenumab Dose 1, erenumab-aooe
Ki Health Partners. LLCRVNC1 — Daxibotulinumtonix A
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