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BMS-986205 reference

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 28, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986205 reference · 3 trials · 1 indication

Phase 1 3
NCT03378310A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference TabletHealthy Volunteers
COMPLETED16 Analytics
NCT03362411A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a TabletHealthy Volunteers
COMPLETED40 Analytics
NCT03312426An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy ParticipantsHealthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.
Up to Day 22

Measured by plasma concentration.

Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet.
Up to Day 22

Measured by plasma concentration.

Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Up to 22 days

Measured by plasma concentration.

Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Up to 22 days

Measured by plasma concentration.

Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Up to 22 days

Measured by plasma concentration.

Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Up to 22 days

Measured by plasma concentration.

Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.
Up to 21 days

Measured by plasma concentration.

Area under the plasma concentration-time curve from time zero to 168 hours (AUC[0-168]) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.
Up to 21 days

Measured by plasma concentration.

Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.
Up to 21 days

Measured by plasma concentration.

AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal.
Up to 21 days

Measured by plasma concentration.

Secondary Endpoints

Incidence of non-serious Adverse Events (AEs).
Up to Day 22
Incidence of Serious Adverse Events (SAEs).
Up to Day 22
Incidence of Adverse Events (AEs) leading to discontinuation.
Up to Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Reference tablet followed by BMS-986205 tablet with free baseEXPERIMENTALBMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).
BMS-986205 tablet with free base followed by reference tabletEXPERIMENTALBMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).
BMS-986205 intact tablet orally then crushed tablet orallyEXPERIMENTALSingle, 100 mg dose
BMS-986205 crushed tablet orally, then intact tablet orallyEXPERIMENTALSingle, 100 mg dose
BMS-986205 intact tablet orally then suspension via NG tubeEXPERIMENTALSingle, 100 mg dose
BMS-986205 suspension via NG tube then intact tablet orallyEXPERIMENTALSingle, 100 mg dose
BMS-986205 under fasted conditions then with high-fat meal.EXPERIMENTALSingle, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a high-fat meal (Day 15).
BMS-986205 with high-fat meal then under fasted conditions.EXPERIMENTALSingle, 100 mg dose of BMS-986205 with a high-fat meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).
BMS-986205 under fasted conditions then with light meal.EXPERIMENTALSingle, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a light meal (Day 15).
BMS-986205 with light meal then under fasted conditions.EXPERIMENTALSingle, 100 mg dose of BMS-986205 with a light meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).

Interventions

NameTypeDescription
BMS-986205 reference tabletDRUGSingle, 100 mg oral dose.
BMS-986205 tablet with free baseDRUGSingle, 100 mg oral dose.
BMS-986205DRUGSingle 100 mg dose on Day 1 and Day 15
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed, written informed consent. * Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests. * Normal renal (kidney) function. * Body Mass Index (BMI) of ...

Countries:United States
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Frequently asked questions about BMS-986205 reference

What is BMS-986205 used for?

BMS-986205 is an investigational small molecule being studied for use in oncology, including advanced cancer, melanoma, and non-small cell lung cancer. It has also been evaluated in healthy participants for bioavailability studies. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes BMS-986205?

BMS-986205 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of this investigational oncology drug in combination with other immunotherapies such as nivolumab and ipilimumab.

What phase is BMS-986205 in?

BMS-986205 is in Phase 1 clinical development. All three completed trials for this drug were Phase 1 studies, including combination trials with nivolumab and ipilimumab in advanced cancers, a Japanese study in advanced tumors, and a bioavailability study in healthy participants.

What clinical trials is BMS-986205 in?

BMS-986205 has been studied in three completed Phase 1 trials: NCT02658890 in advanced cancer and melanoma, NCT03192943 in advanced tumors in Japan, and NCT03374228 in healthy participants. A fourth trial, NCT03792750, studied the drug in Chinese patients with advanced malignant solid tumors.

Is BMS-986205 the same as other drugs?

BMS-986205 is an investigational drug being studied in combination with nivolumab and ipilimumab, which are approved immunotherapies. However, BMS-986205 itself is a distinct small molecule and is not known to be the same as any other approved drug.

How does BMS-986205 work?

BMS-986205 is a small molecule being developed for oncology. While its specific molecular target is not disclosed in the available information, it is being studied in combination with checkpoint inhibitors like nivolumab and ipilimumab to treat advanced cancers.