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BMS-927711

Phase 1

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

BMS-927711 target and mechanism

ModalitySmall molecule

Also known as BMS-927711 (CGRP Antagonist)

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

BMS-927711 clinical trials

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 43 trials

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Frequently asked questions about BMS-927711

What is BMS-927711 used for?

BMS-927711 is an investigational small molecule being studied for the treatment of migraine. It was evaluated in a Phase 1 clinical trial in patients with migraine. It is not approved for any indication and remains in clinical development.

What does BMS-927711 target?

BMS-927711 is a CGRP antagonist, meaning it targets the calcitonin gene-related peptide pathway. This mechanism is being explored for migraine treatment. The drug is a small molecule developed by Pfizer.

Who is developing BMS-927711?

BMS-927711 is being developed by Pfizer, Inc. The company's ticker symbol is PFE. Pfizer is responsible for the clinical development of this investigational migraine therapy.

What phase is BMS-927711 in?

BMS-927711 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The drug is investigational and has not been approved by the FDA.

What clinical trials is BMS-927711 in?

BMS-927711 has been studied in one completed Phase 1 trial, NCT01445067, titled "Study to Evaluate the PK of BMS-927711 in Patient With Migraine During Acute Migraine and Non-migraine Condition." The trial enrolled 48 patients in the United States and was active-controlled.

Is BMS-927711 the same as BMS-927711 (CGRP Antagonist)?

Yes, BMS-927711 is also known as BMS-927711 (CGRP Antagonist). The parenthetical name reflects its mechanism as a CGRP antagonist. Both names refer to the same investigational drug for migraine.