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BMS-927711

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BMS-927711 · 1 trial · 1 indication

Phase 1 1
NCT01445067Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine ConditionMigraine
COMPLETED48 Analytics
PHASE1COMPLETED
Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition
MigraineUnlock trial analytics

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 to 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 30 trials

Frequently asked questions about BMS-927711

What is BMS-927711 used for?

BMS-927711 is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with migraine to evaluate its effects during acute migraine episodes and non-migraine conditions.

Who makes BMS-927711?

BMS-927711 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of migraine.

What phase is BMS-927711 in?

BMS-927711 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of migraine, and its safety and efficacy have not yet been established.

What clinical trials is BMS-927711 in?

BMS-927711 has one completed Phase 1 clinical trial, NCT01445067, which evaluated the pharmacokinetics of the drug in patients with migraine during acute migraine and non-migraine conditions. The trial enrolled 48 participants in the United States and was active-controlled but not double-blinded.

Is BMS-927711 the same as any other drug?

BMS-927711 is a unique investigational compound developed by Pfizer. No alternative names for this drug have been disclosed. It is being studied specifically for the treatment of migraine and is not known to be identical to any other marketed medication.