A Study of Experimental Medication BMS-986251, Taken by M... | NCT03329885

NCT03329885

ID	Type	Description	Link
2017-003408-38	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A Single Ascending Dose (SAD) in Healthy Patients	Experimental	Healthy patient will receive single escalating oral doses of BMS-986251 or placebo	Drug: BMS-986251 Other: Placebo
Part B Multiple Ascending Dose (MAD) in Healthy Patients	Experimental	Healthy patients will receive daily escalating oral doses of BMS-986251 or placebo	Drug: BMS-986251 Other: Placebo
Part C Multiple Dosing in Psoriasis Patients	Experimental	Psoriasis patients will receive daily escalating oral doses of BMS-986251 or placebo	Drug: BMS-986251 Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986251	Drug	Escalating oral dose	Part A Single Ascending Dose (SAD) in Healthy Patients Part B Multiple Ascending Dose (MAD) in Healthy Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization	AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)
Number of Participants With Potentially Clinically Significant Changes in Vital Signs	Vital signs (Systolic and diastolic blood pressure and pulse) were recorded after the participant had been resting for at least 5 minutes in the supine position.	Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters	The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTcinterval, (Fridericia's) and the interpretation of the ECG profile by the Investigator	Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters	Hematology: Hemoglobin, Hematocrit, Total leukocyte count, including differential Platelet count, Red blood cell count, Reticulocyte count; Chemistry: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Direct bilirubin, Alkaline phosphatase, Lactate dehydrogenase , (LDH), Creatinine, Urea, Uric acid, Fasting glucose, High sensitivity C-reactive protein (hs-CRP), Total protein, Albumin Sodium, Potassium, Chloride, Calcium Inorganic phosphate, Magnesium, Creatine kinase, Creatinine clearance (CLcr)- screening only, Cholesterol Triglycerides, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Urinalysis: Protein, Glucose, Blood Leukocyte esterase, Specific gravity, pH,Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick; Other Analyses: Urine test for alcohol, Urine test for drugs of abuse, Pregnancy test

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Inhibition [I(Max)]	Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters	Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24
Time of Maximum Observed Inhibition [t(Imax)]

Eligibility Module

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria (Healthy Patients):

Males and females, ages 18 to 55 years, inclusive, at screening
Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, vital signs, and clinical laboratory results
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
Body weight between 55 kg and 105 kg, inclusive, at screening
Women must not be breastfeeding

Exclusion Criteria (Healthy Patients):

Previous participation in the current study
Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
Employees of PRA or the Sponsor and their relatives
Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Inclusion Criteria (Psoriasis Patients):

Males and females, ages 18 to 70 years, inclusive, at screening
BMI of 18.0 to 35.0 kg/m2, inclusive, at screening
Body weight between 55 kg and 120 kg, inclusive, at screening
Diagnosed with stable chronic plaque psoriasis, for at least 6 months prior to screening and be candidates for either photo-therapy or systemic treatment
Moderate-to-severe intensity of psoriasis as defined by:
1. Affected body surface area (BSA) of ≥10%
2. Psoriasis Area and Severity Index (PASI) ≥12
3. Physician Global Assessment (PGA; 6-point scale) ≥3

Exclusion Criteria (Psoriasis Patients):

Previous participation in the current study
Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
Employees of PRA or the Sponsor and their relatives
Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Other protocol defined inclusion/exclusion criteria could apply

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Groningen		9728 NZ	Netherlands

References Module

Label	URL
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
FG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 21, 2017	Jun 26, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Part C Multiple Dosing in Psoriasis Patients

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

FG0080 subjectsDue to early termination of study, Part C was cancelled and no patients were dosed

All demographic characteristics for Part A are summarized. Due to early termination of the study, only 1 participant was enrolled in the placebo group and 1 participant in the BMS-986251 group in Part B. Part B demographics data is not reported for privacy reasons.

Arm/Group Information

ID	Title	Description
BG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG003	Part A: BMS-986251 15 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG004	Part A: BMS-986251 30 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG005	Part A : BMS-986251 60 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0016 BG0026 BG0036 BG0046 BG0053 BG00636

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00030.9± 10.46 BG00134.5± 7.96 BG00232.3± 11.64 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0015 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization

All participants who had received at least one dose of BMS-986251 or placebo.

Posted

Count of Participants

Participants

AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG004	Part A: BMS-986251 30 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG005	Part A : BMS-986251 60 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG006	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG007	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG0009 OG0016 OG0026 OG003

Title

Denominators

Categories

% of participants that experienced SAEs

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Potentially Clinically Significant Changes in Vital Signs

Vital signs (Systolic and diastolic blood pressure and pulse) were recorded after the participant had been resting for at least 5 minutes in the supine position.

All participants who had received at least one dose of BMS-986251 or placebo.

Posted

Count of Participants

Participants

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters

The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTcinterval, (Fridericia's) and the interpretation of the ECG profile by the Investigator

All participants who had received at least one dose of BMS-986251 or placebo.

Posted

Count of Participants

Participants

Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters

Hematology: Hemoglobin, Hematocrit, Total leukocyte count, including differential Platelet count, Red blood cell count, Reticulocyte count; Chemistry:

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Direct bilirubin, Alkaline phosphatase, Lactate dehydrogenase , (LDH), Creatinine, Urea, Uric acid, Fasting glucose, High sensitivity C-reactive protein (hs-CRP), Total protein, Albumin Sodium, Potassium, Chloride, Calcium Inorganic phosphate, Magnesium, Creatine kinase, Creatinine clearance (CLcr)- screening only, Cholesterol Triglycerides, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Urinalysis: Protein, Glucose, Blood Leukocyte esterase, Specific gravity, pH,Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick; Other Analyses: Urine test for alcohol, Urine test for drugs of abuse, Pregnancy test

All participants who had received at least one dose of BMS-986251 or placebo.

Posted

Count of Participants

Participants

Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo

Primary

Maximum Observed Plasma Concentration (Cmax)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.

Posted

Mean

Standard Deviation

ng/mL

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Time of Maximum Observed Plasma Concentration (Tmax)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Median

Full Range

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)]

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

ng.h/mL

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] (Part A)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

ng.h/mL

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)]

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Apparent (Oral) Clearance (CL/F) Calculated as Dose/[AUC(0-inf)] for Single Dose

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

L/h

Part A: Day 1, Part B: Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Apparent Volume of Distribution at Terminal Phase [V(z)/F]

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Cumulative Urinary Excretion (of the Unchanged Drug) [Ae(t)]

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%]

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Percentage of dose

Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Renal Clearance [CL(R)]

Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

L/h

Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Primary

Area Under the Concentration-time Curve Over 24 Hours (One Dosing Interval) [AUC(0-24)] (Part B)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

ng.h/mL

Part B : Days 1 and Day 14

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Primary

Ratio of AUC(0-24) Following Last Dose to AUC(0-24) Following First Dose [AR[AUC(0-24)]] (Part B)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Ratio

Part B : Day 14

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Primary

Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

Ratio

Part B : Day 14

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Primary

Pre-dose Plasma Concentration (Cpre) (Part B)

PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified

Posted

Mean

Standard Deviation

ng/mL

Part B : Days 2-14

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Secondary

Maximum Observed Inhibition [I(Max)]

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.

Posted

Mean

Standard Deviation

Percent inhibition

Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Secondary

Time of Maximum Observed Inhibition [t(Imax)]

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Posted

Median

Full Range

Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Secondary

Time of Inhibition Above 50% [t(I>50%)]

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Posted

Mean

Standard Deviation

Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Secondary

Time of Inhibition Above 90% [t(I>90%)]

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Posted

Mean

Standard Deviation

Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24

ID	Title	Description
OG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo
OG003	Part A: BMS-986251 15 mg

Secondary

Pre-dose Inhibition [I(Pre)] (Part B)

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Posted

Mean

Standard Deviation

Percent inhibition

Part B : Days 2, 4, 7, and 14

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Primary

Inhibition at Time t [I(t)] (Part B)

Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters

Posted

Mean

Standard Deviation

Percent inhibition

Part B : Days 16, 20, and 24

ID	Title	Description
OG000	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo
OG001	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Placebo	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	9	9	5	9
EG001	Part A: BMS-986251 2 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	6	6	4	6
EG002	Part A: BMS-986251 6 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	6	6	4	6
EG003	Part A: BMS-986251 15 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	6	6	5	6
EG004	Part A: BMS-986251 30 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	6	6	4	6
EG005	Part A : BMS-986251 60 mg	Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo	3	3	3	3
EG006	Part B: Placebo	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	1	1	0	1
EG007	Part B: 3 mg QD (Once Daily)	Part B Multiple Ascending Dose (MAD) in Healthy Participants; daily escalating oral doses of BMS-986251 or placebo	1	1	0	1

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0012 affected6 at risk EG0020 affected6 at risk EG0030 affected6 at risk EG0041 affected6 at risk EG0050 affected3 at risk EG0060 affected1 at risk EG0070 affected1 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Food Poisoning	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Vessel Puncture Site Reaction	General disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Catheter Site Haematoma	General disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Catheter Site Related Reaction	General disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Complication Associated With Device	General disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Medical Device Site Reaction	General disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version v21.0	Systematic Assessment	EG0002 affected9 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Poor Quality Sleep	Nervous system disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA version v21.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003

Due to the early termination of the study, only one participant was exposed to multiple doses of BMS-986251.

Certain Agreements

ID	Term
D001172	Arthritis, Rheumatoid
D011565	Psoriasis
D013167	Spondylitis, Ankylosing
D015212	Inflammatory Bowel Diseases
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D000844	Ankylosis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases
D005234	Fatty Liver
D008107	Liver Diseases

Part A Single Ascending Dose (SAD) in Healthy Participants; single escalating oral doses of BMS-986251 or placebo

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0042 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0041 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0041 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0041 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0042 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0051 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0051 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0041 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0043 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0051 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0051 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk

EG0040 affected6 at risk

EG0050 affected3 at risk

EG0060 affected1 at risk

EG0070 affected1 at risk