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BMS-986165-01

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

BMS-986165-01 is an investigational small molecule being developed for the treatment of lupus. It is currently in Phase 1 clinical development, and it has been studied in a completed clinical trial involving healthy volunteers in the United Kingdom.

Who makes BMS-986165-01?

BMS-986165-01 is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY. The company is conducting clinical research on this investigational small molecule for lupus.

What phase is BMS-986165-01 in?

BMS-986165-01 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and pharmacokinetics.

What clinical trials is BMS-986165-01 in?

BMS-986165-01 has one completed clinical trial, NCT04065932, titled "A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets." This Phase 1 study enrolled 33 participants in the United Kingdom and included healthy volunteers.

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

BMS-986165-01 is a specific formulation or version of the investigational compound BMS-986165. The clinical trial NCT04065932 evaluated the pharmacokinetic profile of BMS-986165 tablets, which is the drug being developed for lupus.