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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials3
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03378310A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference TabletPHASE1 COMPLETED 16 — — Dec 21, 2017Feb 22, 2018Feb 28, 20181 United States
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 TabletPHASE1 COMPLETED 40 — — Nov 9, 2017Feb 1, 2018Feb 23, 20181 United States
NCT03312426An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy ParticipantsPHASE1 COMPLETED 32 — — Oct 9, 2017Nov 22, 2017Jan 19, 20181 United States
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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 — 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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