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BMS-927711

Phase 1

Migraine | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Mar 1, 2023

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01445067Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine ConditionPHASE1 COMPLETED 48 — — Nov 1, 2011Sep 1, 2012Mar 1, 20234 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Time of maximum observed plasma concentration (Tmax) of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Area under the plasma concentration-time curve from time zero to 24 hours post dose [AUC(0-24)] of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Observed plasma concentration at 0.5 hr (C0.5h) of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Observed plasma concentration at 2h (C2h) of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Apparent total body clearance (CLT/F) of BMS-927711 will be derived from plasma concentration versus time
PK samples will be collected for up to 24 hours after the dosing
Secondary Endpoints
Maximum observed plasma concentration (Cmax) will be derived from plasma concentration versus time
From Day 1 0 hour to Day 2 24 hour time points
Time of maximum observed plasma concentration (Tmax) will be derived from plasma concentration versus time
From Day 1 0 hour to Day 2 24 hour time points
Area under the plasma concentration-time curve from time zero to 24 hours post dose [AUC (0-24)] will be derived from plasma concentration versus time
From Day 1 0 hour to Day 2 24 hour time points
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: BMS-927711 (300 mg)ACTIVE_COMPARATOR -
Arm 2: BMS-927711 (600 mg)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BMS-927711 (CGRP Antagonist)DRUGCapsule, Oral, 300 mg, Once, One day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patients with migraine with or without aura who are otherwise healthy as determined by medical history, physical examination, clinical laboratory evaluations and 12-lead electrocardiogram (ECG), will be eligible * Men or women \[women of childbearing potential (WOCBP) or Women...

Countries:United States
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Competitive Landscape -Migraine 32 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV15PHASE3Atogepant, Topiramate, Ubrogepant, MEDI0618
Pfizer Inc.PFE9PHASE3Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment
Eli Lilly and CompanyLLY2PHASE3Galcanezumab
Amgen Inc.AMGN2PHASE3Erenumab Dose 1, erenumab-aooe
Ki Health Partners. LLCRVNC1 — Daxibotulinumtonix A
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