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BMS-986165-01

Phase 1

Lupus | Small molecule | Immunology |Bristol-Myers Squibb Company|Trials Updated: Jan 6, 2021

BMS-986165-01 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2019

BMS-986165-01 target and mechanism

ModalitySmall molecule

Also known as Reference Treatment- BMS-986165-01

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

BMS-986165-01 clinical trials

BMS-986165-01 · 1 trial · 1 indication

Phase 1 1
NCT04065932A Study to Determine the Pharmacokinetic Profile of BMS-986165 TabletsLupus
COMPLETED33 Analytics
PHASE1COMPLETED
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) for BMS-986165
Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
Day 1 of treatment

Secondary Endpoints

Time to maximum observed plasma concentration-(Tmax) for BMS -986165
Day 1 of treatment
Apparent plasma elimination half-life- (T-HALF) for BMS-986165
Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
Day 1 of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-985165-01 prototype formulation 1EXPERIMENTAL -
BMS-986165 TabletEXPERIMENTAL -
BMS-985165-01 prototype formulation 2EXPERIMENTAL -
BMS-985165-01 prototype formulation 3EXPERIMENTAL -
BMS-985165-01 prototype formulation 3 or 4EXPERIMENTAL -
BMS-985165-01 prototype formulation 3, 4 or 5EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986165-01DRUGParticipants will receive BMS- 986165 -01 in prototype formulation
BMS-986165 TabletDRUGParticipants will receive BMS-986165 in tablet form.
FamotidineDRUGParticipants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients must be willing and able to complete all study-specific procedures and visits * Healthy patients, as determined by no clinically significant deviati...

Countries:United Kingdom
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Frequently asked questions about BMS-986165-01

What is BMS-986165-01?

BMS-986165-01 is an investigational small molecule developed by Bristol-Myers Squibb Company for lupus, an immunology condition. It has been studied in a Phase 1 clinical trial conducted in the United Kingdom. It is also referred to as Reference Treatment- BMS-986165-01 in study documentation.

What is BMS-986165-01 used for?

BMS-986165-01 has been studied for lupus, an autoimmune disease in the immunology therapeutic area. The single completed Phase 1 trial enrolled healthy adult volunteers rather than patients with active lupus, and it was designed to characterize the pharmacokinetic profile of the tablet formulation.

Who makes BMS-986165-01?

Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-986165-01. The company sponsored the Phase 1 study of the compound in lupus.

What phase is BMS-986165-01 in?

BMS-986165-01 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study was randomized and controlled but not double blind, and it enrolled 33 participants.

What clinical trials is BMS-986165-01 in?

BMS-986165-01 has been evaluated in one completed Phase 1 trial, NCT04065932, titled A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets. The trial enrolled 33 healthy volunteers aged 18 years and older in the United Kingdom and included both male and female participants.

Is BMS-986165-01 the same as Reference Treatment- BMS-986165-01?

Yes. BMS-986165-01 is also known as Reference Treatment- BMS-986165-01. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb for lupus, so search results under either name describe the same Phase 1 compound.