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Study of BMS-986158 in Subjects With Select Advanced Cancers

A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02419417
Acronym
BET
Enrollment
83
Registered
2015-04-17
Start date
2015-06-19
Completion date
2021-03-17
Last updated
2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Tumors

Brief summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Interventions

Specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Must have select advanced cancers with specific genetic profiles * Must have received appropriate standard of care * At least one measurable lesion at baseline * Expected to have life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion criteria

* Concomitant second malignancies * Uncontrolled or significant cardiovascular disease * Inadequate bone marrow function * Chronic gastrointestinal illness * Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor Other protocol defined inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Experiencing Adverse EventsFrom first dose to 30 days following last dose (up to approximately 29 months)Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Number of Participants With Abnormal Hepatic Test ValuesFrom first dose to 30 days following last dose (up to approximately 29 months)Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

Secondary

MeasureTime frameDescription
Best Overall Response (BOR)From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.
Objective Response Rate (ORR)From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)
Duration of Response (DOR)From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first.
Progression Free Survival (PFS)From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.
Progression Free Survival Rate (PFSR)From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dosePFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses
Maximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported separately for the parent BMS-986158 and its metabolite BMT-161485
Apparent Total Body Clearance (CLT/F) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported only for the parent BMS-986158
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose AdministrationFrom drug administration in Cycle 1 Day 1 to 168 hours post drug administrationValues are reported only for the parent BMS-986158
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Concentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Trough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationFrom Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for the first and last collection
Accumulation Index (AI) - Multiple Dose AdministrationCycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24. Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationCycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose AdministrationCycle 1 Day 1
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationFrom Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
Change From Baseline in Electrocardiogram Parameter QTcFFrom Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.

Countries

Australia, Canada, France, Spain, United States

Participant flow

Pre-assignment details

83 participants were treated.

Participants by arm

ArmCount
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
5
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
4
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
13
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
13
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
4
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
4
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
6
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
13
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
1
Total83

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010
Overall StudyAdverse event unrelated to study drug00002101000
Overall StudyDisease progression541310103451390
Overall StudyParticipant request to discontinue00000000010
Overall StudyStudy drug toxicity00001000000
Overall StudyWithdrawal by Subject00000000001

Baseline characteristics

CharacteristicPart 1 Schedule A - BMS-986158 1.25 mgPart 1 Schedule A - BMS-986158 2 mgPart 1 Schedule A - BMS-986158 3 mgPart 1 Schedule A - BMS-986158 4.5 mgPart 1 Schedule B - BMS-986158 2 mgPart 1 Schedule B - BMS-986158 3 mgPart 1 Schedule C - BMS-986158 2 mgPart 1 Schedule C - BMS-986158 3 mgPart 1 Schedule C - BMS-986158 4.5 mgPart 1 Schedule A - BMS-986158 0.75 mgPart 2 Schedule ATotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants6 Participants3 Participants3 Participants1 Participants2 Participants0 Participants1 Participants3 Participants1 Participants0 Participants20 Participants
Age, Categorical
Between 18 and 65 years
4 Participants7 Participants7 Participants10 Participants3 Participants2 Participants6 Participants12 Participants7 Participants4 Participants1 Participants63 Participants
Age, Continuous45.0 Years
STANDARD_DEVIATION 9.4
63.2 Years
STANDARD_DEVIATION 12.1
54.3 Years
STANDARD_DEVIATION 16.4
55.5 Years
STANDARD_DEVIATION 15.4
61.3 Years
STANDARD_DEVIATION 3
68.5 Years
STANDARD_DEVIATION 5.4
58.8 Years
STANDARD_DEVIATION 2.7
53.6 Years
STANDARD_DEVIATION 9.1
58.1 Years
STANDARD_DEVIATION 9.9
61.4 Years
STANDARD_DEVIATION 7.2
30.0 Years57.3 Years
STANDARD_DEVIATION 12.2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants6 Participants6 Participants5 Participants2 Participants2 Participants4 Participants4 Participants6 Participants0 Participants1 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants7 Participants4 Participants8 Participants2 Participants2 Participants1 Participants8 Participants3 Participants5 Participants0 Participants43 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants2 Participants0 Participants0 Participants0 Participants4 Participants1 Participants0 Participants0 Participants8 Participants
Race (NIH/OMB)
White
3 Participants11 Participants10 Participants10 Participants4 Participants4 Participants6 Participants8 Participants8 Participants5 Participants0 Participants69 Participants
Sex: Female, Male
Female
3 Participants12 Participants7 Participants9 Participants2 Participants3 Participants5 Participants9 Participants9 Participants5 Participants0 Participants64 Participants
Sex: Female, Male
Male
1 Participants1 Participants3 Participants4 Participants2 Participants1 Participants1 Participants4 Participants1 Participants0 Participants1 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
deaths
Total, all-cause mortality
5 / 53 / 410 / 138 / 1012 / 133 / 43 / 44 / 610 / 137 / 100 / 1
other
Total, other adverse events
5 / 54 / 412 / 1310 / 1013 / 134 / 44 / 46 / 613 / 139 / 101 / 1
serious
Total, serious adverse events
3 / 53 / 47 / 137 / 109 / 132 / 42 / 44 / 65 / 133 / 100 / 1

Outcome results

Primary

Number of Participants Experiencing Adverse Events

Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Time frame: From first dose to 30 days following last dose (up to approximately 29 months)

Population: All treated participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)3 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants Experiencing Adverse EventsDeaths0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)5 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)3 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants Experiencing Adverse EventsDeaths1 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)4 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)13 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsDeaths2 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)7 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)7 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)10 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsDeaths4 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)9 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation3 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsDeaths3 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)13 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsDeaths0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)4 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)2 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation1 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsDeaths0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)4 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)2 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)4 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation1 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsDeaths1 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)6 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)13 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsDeaths2 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)5 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)3 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsAdverse Events (AEs)9 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants Experiencing Adverse EventsDeaths0 Participants
Part 2 Schedule ANumber of Participants Experiencing Adverse EventsSerious Adverse Events (SAEs)0 Participants
Part 2 Schedule ANumber of Participants Experiencing Adverse EventsDeaths0 Participants
Part 2 Schedule ANumber of Participants Experiencing Adverse EventsAEs leading to discontinuation0 Participants
Part 2 Schedule ANumber of Participants Experiencing Adverse EventsAdverse Events (AEs)1 Participants
Primary

Number of Participants With Abnormal Hepatic Test Values

Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

Time frame: From first dose to 30 days following last dose (up to approximately 29 months)

Population: All treated participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY1 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS1 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN1 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN1 Participants
Part 1 Schedule A - BMS-986158 0.75 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN1 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN2 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN0 Participants
Part 1 Schedule A - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN1 Participants
Part 1 Schedule A - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN1 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN2 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN4 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule A - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule B - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN1 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS1 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN1 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule B - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN0 Participants
Part 1 Schedule C - BMS-986158 2 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN0 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN2 Participants
Part 1 Schedule C - BMS-986158 3 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN1 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN1 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY1 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN2 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS1 Participants
Part 1 Schedule C - BMS-986158 4.5 mgNumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesTOTAL BILIRUBIN > 2XULN1 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 3XULN0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 5XULN0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 10XULN0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesALT OR AST > 20XULN0 Participants
Part 2 Schedule ANumber of Participants With Abnormal Hepatic Test ValuesCONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS0 Participants
Secondary

Accumulation Index (AI) - Multiple Dose Administration

AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24. Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.

Time frame: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C244.63 RatioGeometric Coefficient of Variation 58
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC245.06 RatioGeometric Coefficient of Variation 45
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC242.60 RatioGeometric Coefficient of Variation 35
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C242.58 RatioGeometric Coefficient of Variation 51
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax4.53 RatioGeometric Coefficient of Variation 54
Part 1 Schedule A - BMS-986158 0.75 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.89 RatioGeometric Coefficient of Variation 20
Part 1 Schedule A - BMS-986158 1.25 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax3.44 RatioGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 1.25 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.72 RatioGeometric Coefficient of Variation 20
Part 1 Schedule A - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax2.91 RatioGeometric Coefficient of Variation 27
Part 1 Schedule A - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.76 RatioGeometric Coefficient of Variation 34
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.94 RatioGeometric Coefficient of Variation 42
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C241.79 RatioGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax3.46 RatioGeometric Coefficient of Variation 33
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C243.18 RatioGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC241.95 RatioGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC244.20 RatioGeometric Coefficient of Variation 55
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC242.15 RatioGeometric Coefficient of Variation 23
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.79 RatioGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C242.24 RatioGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax4.45 RatioGeometric Coefficient of Variation 30
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C244.33 RatioGeometric Coefficient of Variation 39
Part 1 Schedule A - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC245.03 RatioGeometric Coefficient of Variation 34
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC241.45 Ratio
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C241.29 Ratio
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax2.40 Ratio
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC242.64 Ratio
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C242.76 Ratio
Part 1 Schedule B - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.35 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C243.05 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax6.35 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C246.23 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax2.37 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC242.78 Ratio
Part 1 Schedule B - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC246.85 Ratio
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC244.66 RatioGeometric Coefficient of Variation 25
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C244.46 RatioGeometric Coefficient of Variation 31
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax4.12 RatioGeometric Coefficient of Variation 36
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC242.34 RatioGeometric Coefficient of Variation 22
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.65 RatioGeometric Coefficient of Variation 13
Part 1 Schedule C - BMS-986158 2 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C242.55 RatioGeometric Coefficient of Variation 24
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C241.98 RatioGeometric Coefficient of Variation 54
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC243.87 RatioGeometric Coefficient of Variation 54
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC241.90 RatioGeometric Coefficient of Variation 46
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax3.08 RatioGeometric Coefficient of Variation 59
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.50 RatioGeometric Coefficient of Variation 38
Part 1 Schedule C - BMS-986158 3 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C244.02 RatioGeometric Coefficient of Variation 42
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - C242.91 RatioGeometric Coefficient of Variation 79
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - Cmax1.59 RatioGeometric Coefficient of Variation 47
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - AUC243.53 RatioGeometric Coefficient of Variation 87
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - C241.42 RatioGeometric Coefficient of Variation 72
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationParent BMS-986158 - AUC241.52 RatioGeometric Coefficient of Variation 59
Part 1 Schedule C - BMS-986158 4.5 mgAccumulation Index (AI) - Multiple Dose AdministrationMetabolite BMT-161485 - Cmax3.21 RatioGeometric Coefficient of Variation 64
Secondary

Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationMetabolite BMT-16148535.3 hr
Part 1 Schedule A - BMS-986158 0.75 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationParent BMS-98615833.7 hrStandard Deviation 1.41
Part 1 Schedule A - BMS-986158 1.25 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationMetabolite BMT-16148550.8 hrStandard Deviation 6.26
Part 1 Schedule A - BMS-986158 1.25 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationParent BMS-98615848.7 hrStandard Deviation 6.66
Part 1 Schedule A - BMS-986158 2 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationParent BMS-98615854.3 hrStandard Deviation 19.87
Part 1 Schedule A - BMS-986158 2 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationMetabolite BMT-16148548.8 hrStandard Deviation 18.78
Part 1 Schedule A - BMS-986158 3 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationParent BMS-98615842.7 hrStandard Deviation 19.56
Part 1 Schedule A - BMS-986158 3 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationMetabolite BMT-16148539.4 hrStandard Deviation 13.8
Part 1 Schedule A - BMS-986158 4.5 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationMetabolite BMT-16148538.7 hrStandard Deviation 13.66
Part 1 Schedule A - BMS-986158 4.5 mgApparent Terminal Phase Half-Life (T-HALF) - Single Dose AdministrationParent BMS-98615843.8 hrStandard Deviation 15.75
Secondary

Apparent Total Body Clearance (CLT/F) - Single Dose Administration

Values are reported only for the parent BMS-986158

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgApparent Total Body Clearance (CLT/F) - Single Dose Administration5.04 mL/minGeometric Coefficient of Variation 17
Part 1 Schedule A - BMS-986158 1.25 mgApparent Total Body Clearance (CLT/F) - Single Dose Administration2.97 mL/minGeometric Coefficient of Variation 18
Part 1 Schedule A - BMS-986158 2 mgApparent Total Body Clearance (CLT/F) - Single Dose Administration3.41 mL/minGeometric Coefficient of Variation 56
Part 1 Schedule A - BMS-986158 3 mgApparent Total Body Clearance (CLT/F) - Single Dose Administration4.28 mL/minGeometric Coefficient of Variation 62
Part 1 Schedule A - BMS-986158 4.5 mgApparent Total Body Clearance (CLT/F) - Single Dose Administration3.95 mL/minGeometric Coefficient of Variation 33
Secondary

Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration

Values are reported only for the parent BMS-986158

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgApparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration14.7 LitersGeometric Coefficient of Variation 21
Part 1 Schedule A - BMS-986158 1.25 mgApparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration12.5 LitersGeometric Coefficient of Variation 18
Part 1 Schedule A - BMS-986158 2 mgApparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration14.8 LitersGeometric Coefficient of Variation 27
Part 1 Schedule A - BMS-986158 3 mgApparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration14.4 LitersGeometric Coefficient of Variation 28
Part 1 Schedule A - BMS-986158 4.5 mgApparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration14.1 LitersGeometric Coefficient of Variation 31
Secondary

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationParent BMS-9861582479 hr*ng/mLGeometric Coefficient of Variation 18
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationMetabolite BMT-161485409 hr*ng/mL
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationParent BMS-9861587013 hr*ng/mLGeometric Coefficient of Variation 17
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationMetabolite BMT-161485892 hr*ng/mLGeometric Coefficient of Variation 13
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationParent BMS-9861589775 hr*ng/mLGeometric Coefficient of Variation 56
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationMetabolite BMT-161485944 hr*ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationMetabolite BMT-1614851128 hr*ng/mLGeometric Coefficient of Variation 46
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationParent BMS-98615811677 hr*ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationParent BMS-98615818974 hr*ng/mLGeometric Coefficient of Variation 40
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose AdministrationMetabolite BMT-1614852231 hr*ng/mLGeometric Coefficient of Variation 67
Secondary

Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12150 h*ng/mLGeometric Coefficient of Variation 15
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint3449 h*ng/mLGeometric Coefficient of Variation 93
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 1314 h*ng/mLGeometric Coefficient of Variation 32
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1474 h*ng/mLGeometric Coefficient of Variation 89
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint4961 h*ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 16372 h*ng/mLGeometric Coefficient of Variation 14
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint691 h*ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 1790 h*ng/mLGeometric Coefficient of Variation 14
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint7612 h*ng/mLGeometric Coefficient of Variation 71
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 18564 h*ng/mLGeometric Coefficient of Variation 48
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 1992 h*ng/mLGeometric Coefficient of Variation 65
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1110 h*ng/mLGeometric Coefficient of Variation 89
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 110452 h*ng/mLGeometric Coefficient of Variation 50
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint13378 h*ng/mLGeometric Coefficient of Variation 77
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 11305 h*ng/mLGeometric Coefficient of Variation 48
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2925 h*ng/mLGeometric Coefficient of Variation 85
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 12748 h*ng/mLGeometric Coefficient of Variation 64
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint29517 h*ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint6691 h*ng/mLGeometric Coefficient of Variation 49
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 119124 h*ng/mLGeometric Coefficient of Variation 46
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 1424 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint6321 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 15202 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1000 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint33978 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 12467 h*ng/mLGeometric Coefficient of Variation 61
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint7339 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 125852 h*ng/mLGeometric Coefficient of Variation 41
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 110931 h*ng/mLGeometric Coefficient of Variation 43
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint5022 h*ng/mLGeometric Coefficient of Variation 62
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint19868 h*ng/mLGeometric Coefficient of Variation 45
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 11895 h*ng/mLGeometric Coefficient of Variation 58
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint3458 h*ng/mLGeometric Coefficient of Variation 96
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 111493 h*ng/mLGeometric Coefficient of Variation 54
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 11219 h*ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint18266 h*ng/mLGeometric Coefficient of Variation 97
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 day 12645 h*ng/mLGeometric Coefficient of Variation 77
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 117220 h*ng/mLGeometric Coefficient of Variation 84
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint5719 h*ng/mLGeometric Coefficient of Variation 134
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint19995 h*ng/mLGeometric Coefficient of Variation 135
Secondary

Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 198.2 h*ng/mLGeometric Coefficient of Variation 34
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint2716 h*ng/mLGeometric Coefficient of Variation 51
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint550 h*ng/mLGeometric Coefficient of Variation 81
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11027 h*ng/mLGeometric Coefficient of Variation 16
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1188 h*ng/mLGeometric Coefficient of Variation 11
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12309 h*ng/mLGeometric Coefficient of Variation 13
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint3852 h*ng/mL
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint500 h*ng/mL
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1290 h*ng/mLGeometric Coefficient of Variation 22
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 13610 h*ng/mLGeometric Coefficient of Variation 22
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1746 h*ng/mLGeometric Coefficient of Variation 64
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint9817 h*ng/mLGeometric Coefficient of Variation 56
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1404 h*ng/mLGeometric Coefficient of Variation 39
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 14942 h*ng/mLGeometric Coefficient of Variation 43
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint14551 h*ng/mLGeometric Coefficient of Variation 32
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 16786 h*ng/mLGeometric Coefficient of Variation 24
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1560 h*ng/mLGeometric Coefficient of Variation 42
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2649 h*ng/mLGeometric Coefficient of Variation 48
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint3430 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12358 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint505 h*ng/mL
Part 1 Schedule B - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1191 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1439 h*ng/mLGeometric Coefficient of Variation 52
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2551 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint13305 h*ng/mL
Part 1 Schedule B - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 16921 h*ng/mLGeometric Coefficient of Variation 28
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1765 h*ng/mLGeometric Coefficient of Variation 51
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1367 h*ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 13660 h*ng/mLGeometric Coefficient of Variation 27
Part 1 Schedule C - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint8561 h*ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 14468 h*ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint8637 h*ng/mLGeometric Coefficient of Variation 71
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1337 h*ng/mLGeometric Coefficient of Variation 46
Part 1 Schedule C - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1299 h*ng/mLGeometric Coefficient of Variation 63
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint11286 h*ng/mLGeometric Coefficient of Variation 104
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 17418 h*ng/mLGeometric Coefficient of Variation 43
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2616 h*ng/mLGeometric Coefficient of Variation 102
Part 1 Schedule C - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 1741 h*ng/mLGeometric Coefficient of Variation 38
Secondary

Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationParent BMS-9861581027 hr*ng/mLGeometric Coefficient of Variation 16
Part 1 Schedule A - BMS-986158 0.75 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationMetabolite BMT-16148598.2 hr*ng/mLGeometric Coefficient of Variation 34
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationParent BMS-9861582309 hr*ng/mLGeometric Coefficient of Variation 13
Part 1 Schedule A - BMS-986158 1.25 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationMetabolite BMT-161485188 hr*ng/mLGeometric Coefficient of Variation 11
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationParent BMS-9861583533 hr*ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule A - BMS-986158 2 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationMetabolite BMT-161485310 hr*ng/mLGeometric Coefficient of Variation 35
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationMetabolite BMT-161485377 hr*ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule A - BMS-986158 3 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationParent BMS-9861584989 hr*ng/mLGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationParent BMS-9861587039 hr*ng/mLGeometric Coefficient of Variation 34
Part 1 Schedule A - BMS-986158 4.5 mgArea Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose AdministrationMetabolite BMT-161485629 hr*ng/mLGeometric Coefficient of Variation 41
Secondary

Best Overall Response (BOR)

BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.

Time frame: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

Population: All treated participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 1 Schedule A - BMS-986158 0.75 mgBest Overall Response (BOR)Unable to determine0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule A - BMS-986158 0.75 mgBest Overall Response (BOR)Stable Disease1 Participants
Part 1 Schedule A - BMS-986158 0.75 mgBest Overall Response (BOR)Progressive Disease4 Participants
Part 1 Schedule A - BMS-986158 1.25 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgBest Overall Response (BOR)Progressive Disease2 Participants
Part 1 Schedule A - BMS-986158 1.25 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule A - BMS-986158 1.25 mgBest Overall Response (BOR)Stable Disease1 Participants
Part 1 Schedule A - BMS-986158 1.25 mgBest Overall Response (BOR)Unable to determine1 Participants
Part 1 Schedule A - BMS-986158 2 mgBest Overall Response (BOR)Stable Disease2 Participants
Part 1 Schedule A - BMS-986158 2 mgBest Overall Response (BOR)Unable to determine3 Participants
Part 1 Schedule A - BMS-986158 2 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule A - BMS-986158 2 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule A - BMS-986158 2 mgBest Overall Response (BOR)Progressive Disease8 Participants
Part 1 Schedule A - BMS-986158 3 mgBest Overall Response (BOR)Progressive Disease7 Participants
Part 1 Schedule A - BMS-986158 3 mgBest Overall Response (BOR)Stable Disease1 Participants
Part 1 Schedule A - BMS-986158 3 mgBest Overall Response (BOR)Unable to determine2 Participants
Part 1 Schedule A - BMS-986158 3 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule A - BMS-986158 3 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule A - BMS-986158 4.5 mgBest Overall Response (BOR)Unable to determine2 Participants
Part 1 Schedule A - BMS-986158 4.5 mgBest Overall Response (BOR)Stable Disease7 Participants
Part 1 Schedule A - BMS-986158 4.5 mgBest Overall Response (BOR)Progressive Disease3 Participants
Part 1 Schedule A - BMS-986158 4.5 mgBest Overall Response (BOR)Partial Response1 Participants
Part 1 Schedule A - BMS-986158 4.5 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule B - BMS-986158 2 mgBest Overall Response (BOR)Stable Disease2 Participants
Part 1 Schedule B - BMS-986158 2 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule B - BMS-986158 2 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule B - BMS-986158 2 mgBest Overall Response (BOR)Progressive Disease2 Participants
Part 1 Schedule B - BMS-986158 2 mgBest Overall Response (BOR)Unable to determine0 Participants
Part 1 Schedule B - BMS-986158 3 mgBest Overall Response (BOR)Stable Disease1 Participants
Part 1 Schedule B - BMS-986158 3 mgBest Overall Response (BOR)Unable to determine1 Participants
Part 1 Schedule B - BMS-986158 3 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule B - BMS-986158 3 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule B - BMS-986158 3 mgBest Overall Response (BOR)Progressive Disease2 Participants
Part 1 Schedule C - BMS-986158 2 mgBest Overall Response (BOR)Stable Disease1 Participants
Part 1 Schedule C - BMS-986158 2 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule C - BMS-986158 2 mgBest Overall Response (BOR)Unable to determine3 Participants
Part 1 Schedule C - BMS-986158 2 mgBest Overall Response (BOR)Progressive Disease2 Participants
Part 1 Schedule C - BMS-986158 2 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule C - BMS-986158 3 mgBest Overall Response (BOR)Stable Disease4 Participants
Part 1 Schedule C - BMS-986158 3 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule C - BMS-986158 3 mgBest Overall Response (BOR)Progressive Disease9 Participants
Part 1 Schedule C - BMS-986158 3 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule C - BMS-986158 3 mgBest Overall Response (BOR)Unable to determine0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgBest Overall Response (BOR)Complete Response0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgBest Overall Response (BOR)Progressive Disease4 Participants
Part 1 Schedule C - BMS-986158 4.5 mgBest Overall Response (BOR)Unable to determine2 Participants
Part 1 Schedule C - BMS-986158 4.5 mgBest Overall Response (BOR)Partial Response0 Participants
Part 1 Schedule C - BMS-986158 4.5 mgBest Overall Response (BOR)Stable Disease4 Participants
Part 2 Schedule ABest Overall Response (BOR)Progressive Disease0 Participants
Part 2 Schedule ABest Overall Response (BOR)Stable Disease0 Participants
Part 2 Schedule ABest Overall Response (BOR)Partial Response1 Participants
Part 2 Schedule ABest Overall Response (BOR)Complete Response0 Participants
Part 2 Schedule ABest Overall Response (BOR)Unable to determine0 Participants
Secondary

Change From Baseline in Electrocardiogram Parameter QTcF

QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.

Time frame: From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).

Population: All treated participants with available measurements at the indicated timepoints. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgChange From Baseline in Electrocardiogram Parameter QTcF-6.8 msecStandard Deviation 11.63
Part 1 Schedule A - BMS-986158 1.25 mgChange From Baseline in Electrocardiogram Parameter QTcF-5.3 msec
Part 1 Schedule A - BMS-986158 2 mgChange From Baseline in Electrocardiogram Parameter QTcF-3.3 msecStandard Deviation 22.48
Part 1 Schedule A - BMS-986158 3 mgChange From Baseline in Electrocardiogram Parameter QTcF-5.4 msecStandard Deviation 18.45
Part 1 Schedule A - BMS-986158 4.5 mgChange From Baseline in Electrocardiogram Parameter QTcF-10.2 msecStandard Deviation 22.43
Part 1 Schedule B - BMS-986158 2 mgChange From Baseline in Electrocardiogram Parameter QTcF-10.7 msecStandard Deviation 15.1
Part 1 Schedule B - BMS-986158 3 mgChange From Baseline in Electrocardiogram Parameter QTcF-16.7 msec
Part 1 Schedule C - BMS-986158 2 mgChange From Baseline in Electrocardiogram Parameter QTcF-7.7 msecStandard Deviation 10.98
Part 1 Schedule C - BMS-986158 3 mgChange From Baseline in Electrocardiogram Parameter QTcF14.3 msecStandard Deviation 14.03
Part 1 Schedule C - BMS-986158 4.5 mgChange From Baseline in Electrocardiogram Parameter QTcF-0.6 msecStandard Deviation 10.75
Secondary

Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 133.5 ng/mLGeometric Coefficient of Variation 18
Part 1 Schedule A - BMS-986158 0.75 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint87.9 ng/mLGeometric Coefficient of Variation 63
Part 1 Schedule A - BMS-986158 0.75 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 14.85 ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 0.75 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint16.4 ng/mLGeometric Coefficient of Variation 91
Part 1 Schedule A - BMS-986158 1.25 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint22.3 ng/mLGeometric Coefficient of Variation 22
Part 1 Schedule A - BMS-986158 1.25 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 167.4 ng/mLGeometric Coefficient of Variation 12
Part 1 Schedule A - BMS-986158 1.25 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 17.92 ng/mLGeometric Coefficient of Variation 8
Part 1 Schedule A - BMS-986158 1.25 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint116 ng/mL
Part 1 Schedule A - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint33.7 ng/mLGeometric Coefficient of Variation 55
Part 1 Schedule A - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1108 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 112.0 ng/mLGeometric Coefficient of Variation 37
Part 1 Schedule A - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1143 ng/mLGeometric Coefficient of Variation 50
Part 1 Schedule A - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint280 ng/mLGeometric Coefficient of Variation 64
Part 1 Schedule A - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 118.8 ng/mLGeometric Coefficient of Variation 40
Part 1 Schedule A - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint54.0 ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule A - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 127.0 ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule A - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint461 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint89.6 ng/mLGeometric Coefficient of Variation 55
Part 1 Schedule A - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1210 ng/mLGeometric Coefficient of Variation 32
Part 1 Schedule B - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 15.23 ng/mL
Part 1 Schedule B - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint85.1 ng/mL
Part 1 Schedule B - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 166.1 ng/mL
Part 1 Schedule B - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint14.4 ng/mL
Part 1 Schedule B - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint463 ng/mL
Part 1 Schedule B - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 119.0 ng/mLGeometric Coefficient of Variation 42
Part 1 Schedule B - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint104 ng/mL
Part 1 Schedule B - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1232 ng/mLGeometric Coefficient of Variation 30
Part 1 Schedule C - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1112 ng/mLGeometric Coefficient of Variation 33
Part 1 Schedule C - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint69.4 ng/mLGeometric Coefficient of Variation 62
Part 1 Schedule C - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint276 ng/mLGeometric Coefficient of Variation 45
Part 1 Schedule C - BMS-986158 2 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 116.3 ng/mLGeometric Coefficient of Variation 37
Part 1 Schedule C - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint47.8 ng/mLGeometric Coefficient of Variation 74
Part 1 Schedule C - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1125 ng/mLGeometric Coefficient of Variation 43
Part 1 Schedule C - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 112.9 ng/mLGeometric Coefficient of Variation 58
Part 1 Schedule C - BMS-986158 3 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint244 ng/mLGeometric Coefficient of Variation 93
Part 1 Schedule C - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 129.1 ng/mLGeometric Coefficient of Variation 53
Part 1 Schedule C - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1185 ng/mLGeometric Coefficient of Variation 68
Part 1 Schedule C - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint84.5 ng/mLGeometric Coefficient of Variation 120
Part 1 Schedule C - BMS-986158 4.5 mgConcentration at the End of Dosing Interval (C24) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint263 ng/mLGeometric Coefficient of Variation 131
Secondary

Duration of Response (DOR)

DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer \[CRPC or NEPC\]), or death due to any cause, whichever occurs first.

Time frame: From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)

Population: All participants who achieved a Complete Response (CR) or Partial Response (PR)

ArmMeasureValue (MEAN)
Part 1 Schedule A - BMS-986158 4.5 mgDuration of Response (DOR)22.3 Weeks
Part 2 Schedule ADuration of Response (DOR)42.4 Weeks
Secondary

Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.

Time frame: Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615836.0 HoursStandard Deviation 15.99
Part 1 Schedule A - BMS-986158 0.75 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148580.9 HoursStandard Deviation 40.42
Part 1 Schedule A - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615825.7 HoursStandard Deviation 14.86
Part 1 Schedule A - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148572.1 HoursStandard Deviation 47.11
Part 1 Schedule A - BMS-986158 4.5 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615827.3 HoursStandard Deviation 8.72
Part 1 Schedule A - BMS-986158 4.5 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148580.4 HoursStandard Deviation 29.59
Part 1 Schedule B - BMS-986158 2 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615814.4 Hours
Part 1 Schedule B - BMS-986158 2 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148535.2 Hours
Part 1 Schedule B - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-161485105 Hours
Part 1 Schedule B - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615837.3 Hours
Part 1 Schedule C - BMS-986158 2 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148572.7 HoursStandard Deviation 19.42
Part 1 Schedule C - BMS-986158 2 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615831.6 HoursStandard Deviation 10.48
Part 1 Schedule C - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615827.3 HoursStandard Deviation 15.15
Part 1 Schedule C - BMS-986158 3 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148563.5 HoursStandard Deviation 39.53
Part 1 Schedule C - BMS-986158 4.5 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationMetabolite BMT-16148572.8 HoursStandard Deviation 74.17
Part 1 Schedule C - BMS-986158 4.5 mgEffective Elimination Half-Life (Effective T-HALF) - Multiple Dose AdministrationParent BMS-98615827.6 HoursStandard Deviation 19.11
Secondary

Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 168.8 ng/mLGeometric Coefficient of Variation 23
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint136 ng/mLGeometric Coefficient of Variation 43
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 15.00 ng/mLGeometric Coefficient of Variation 30
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint25.8 ng/mLGeometric Coefficient of Variation 82
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint284 ng/mLGeometric Coefficient of Variation 16
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1175 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint31.0 ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 110.0 ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint442 ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1260 ng/mLGeometric Coefficient of Variation 20
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 116.9 ng/mLGeometric Coefficient of Variation 32
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint49.4 ng/mLGeometric Coefficient of Variation 46
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1328 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint624 ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 122.5 ng/mLGeometric Coefficient of Variation 38
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint83.3 ng/mLGeometric Coefficient of Variation 57
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 130.0 ng/mLGeometric Coefficient of Variation 41
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint898 ng/mLGeometric Coefficient of Variation 39
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint126 ng/mLGeometric Coefficient of Variation 50
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1478 ng/mLGeometric Coefficient of Variation 24
Part 1 Schedule B - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 113.6 ng/mL
Part 1 Schedule B - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint279 ng/mL
Part 1 Schedule B - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1207 ng/mL
Part 1 Schedule B - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint32.7 ng/mL
Part 1 Schedule B - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint855 ng/mL
Part 1 Schedule B - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 126.3 ng/mLGeometric Coefficient of Variation 63
Part 1 Schedule B - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint127 ng/mL
Part 1 Schedule B - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1481 ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule C - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1295 ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule C - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint80.7 ng/mLGeometric Coefficient of Variation 53
Part 1 Schedule C - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint520 ng/mLGeometric Coefficient of Variation 34
Part 1 Schedule C - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 121.1 ng/mLGeometric Coefficient of Variation 35
Part 1 Schedule C - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint64.5 ng/mLGeometric Coefficient of Variation 55
Part 1 Schedule C - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1370 ng/mLGeometric Coefficient of Variation 22
Part 1 Schedule C - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 119.4 ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule C - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint588 ng/mLGeometric Coefficient of Variation 47
Part 1 Schedule C - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 145.5 ng/mLGeometric Coefficient of Variation 32
Part 1 Schedule C - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 Day 1567 ng/mLGeometric Coefficient of Variation 24
Part 1 Schedule C - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint146 ng/mLGeometric Coefficient of Variation 83
Part 1 Schedule C - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint901 ng/mLGeometric Coefficient of Variation 62
Secondary

Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationParent BMS-98615868.8 ng/mLGeometric Coefficient of Variation 23
Part 1 Schedule A - BMS-986158 0.75 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationMetabolite BMT-1614855.00 ng/mLGeometric Coefficient of Variation 30
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationParent BMS-986158175 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 1.25 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationMetabolite BMT-16148510.0 ng/mLGeometric Coefficient of Variation 29
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationParent BMS-986158269 ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule A - BMS-986158 2 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationMetabolite BMT-16148518.2 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationMetabolite BMT-16148521.6 ng/mLGeometric Coefficient of Variation 47
Part 1 Schedule A - BMS-986158 3 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationParent BMS-986158368 ng/mLGeometric Coefficient of Variation 30
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationParent BMS-986158513 ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule A - BMS-986158 4.5 mgMaximum Observed Plasma Concentration (Cmax) - Single Dose AdministrationMetabolite BMT-16148535.6 ng/mLGeometric Coefficient of Variation 41
Secondary

Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint73.7 ng/mLGeometric Coefficient of Variation 45
Part 1 Schedule A - BMS-986158 0.75 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint16.4 ng/mLGeometric Coefficient of Variation 91
Part 1 Schedule A - BMS-986158 1.25 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint141 ng/mLGeometric Coefficient of Variation 17
Part 1 Schedule A - BMS-986158 1.25 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint22.3 ng/mLGeometric Coefficient of Variation 22
Part 1 Schedule A - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint208 ng/mLGeometric Coefficient of Variation 53
Part 1 Schedule A - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint33.7 ng/mLGeometric Coefficient of Variation 55
Part 1 Schedule A - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint227 ng/mLGeometric Coefficient of Variation 76
Part 1 Schedule A - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint54.0 ng/mLGeometric Coefficient of Variation 73
Part 1 Schedule A - BMS-986158 4.5 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint89.6 ng/mLGeometric Coefficient of Variation 55
Part 1 Schedule A - BMS-986158 4.5 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint428 ng/mLGeometric Coefficient of Variation 41
Part 1 Schedule B - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint14.4 ng/mL
Part 1 Schedule B - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint85.1 ng/mL
Part 1 Schedule B - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint79.5 ng/mL
Part 1 Schedule B - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint435 ng/mL
Part 1 Schedule C - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint270 ng/mLGeometric Coefficient of Variation 42
Part 1 Schedule C - BMS-986158 2 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint59.7 ng/mLGeometric Coefficient of Variation 54
Part 1 Schedule C - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint238 ng/mLGeometric Coefficient of Variation 94
Part 1 Schedule C - BMS-986158 3 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint44.2 ng/mLGeometric Coefficient of Variation 74
Part 1 Schedule C - BMS-986158 4.5 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint253 ng/mLGeometric Coefficient of Variation 125
Part 1 Schedule C - BMS-986158 4.5 mgMinimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint71.1 ng/mLGeometric Coefficient of Variation 115
Secondary

Objective Response Rate (ORR)

ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)

Time frame: From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

Population: All treated participants

ArmMeasureValue (NUMBER)
Part 1 Schedule A - BMS-986158 0.75 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule A - BMS-986158 1.25 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule A - BMS-986158 2 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule A - BMS-986158 3 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule A - BMS-986158 4.5 mgObjective Response Rate (ORR)7.7 Percent of Participants
Part 1 Schedule B - BMS-986158 2 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule B - BMS-986158 3 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule C - BMS-986158 2 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule C - BMS-986158 3 mgObjective Response Rate (ORR)0 Percent of Participants
Part 1 Schedule C - BMS-986158 4.5 mgObjective Response Rate (ORR)0 Percent of Participants
Part 2 Schedule AObjective Response Rate (ORR)100.0 Percent of Participants
Secondary

Progression Free Survival (PFS)

PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.

Time frame: From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)

Population: All treated participants.

ArmMeasureValue (MEDIAN)
Part 1 Schedule A - BMS-986158 0.75 mgProgression Free Survival (PFS)4.57 Weeks
Part 1 Schedule A - BMS-986158 1.25 mgProgression Free Survival (PFS)9.71 Weeks
Part 1 Schedule A - BMS-986158 2 mgProgression Free Survival (PFS)7.57 Weeks
Part 1 Schedule A - BMS-986158 3 mgProgression Free Survival (PFS)7.43 Weeks
Part 1 Schedule A - BMS-986158 4.5 mgProgression Free Survival (PFS)13.79 Weeks
Part 1 Schedule B - BMS-986158 2 mgProgression Free Survival (PFS)24.29 Weeks
Part 1 Schedule B - BMS-986158 3 mgProgression Free Survival (PFS)6.57 Weeks
Part 1 Schedule C - BMS-986158 2 mgProgression Free Survival (PFS)8.29 Weeks
Part 1 Schedule C - BMS-986158 3 mgProgression Free Survival (PFS)8.43 Weeks
Part 1 Schedule C - BMS-986158 4.5 mgProgression Free Survival (PFS)9.14 Weeks
Part 2 Schedule AProgression Free Survival (PFS)NA Weeks
Secondary

Progression Free Survival Rate (PFSR)

PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses

Time frame: From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose

Population: All treated participants.

ArmMeasureGroupValue (NUMBER)
Part 1 Schedule A - BMS-986158 0.75 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 0.75 mgProgression Free Survival Rate (PFSR)12 weeks20.0 Percent of participants
Part 1 Schedule A - BMS-986158 0.75 mgProgression Free Survival Rate (PFSR)24 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 1.25 mgProgression Free Survival Rate (PFSR)24 weeks33.3 Percent of participants
Part 1 Schedule A - BMS-986158 1.25 mgProgression Free Survival Rate (PFSR)12 weeks33.3 Percent of participants
Part 1 Schedule A - BMS-986158 1.25 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 2 mgProgression Free Survival Rate (PFSR)24 weeks9.1 Percent of participants
Part 1 Schedule A - BMS-986158 2 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 2 mgProgression Free Survival Rate (PFSR)12 weeks27.3 Percent of participants
Part 1 Schedule A - BMS-986158 3 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 3 mgProgression Free Survival Rate (PFSR)12 weeks11.1 Percent of participants
Part 1 Schedule A - BMS-986158 3 mgProgression Free Survival Rate (PFSR)24 weeks11.1 Percent of participants
Part 1 Schedule A - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)24 weeks30.0 Percent of participants
Part 1 Schedule A - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule A - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)12 weeks50.0 Percent of participants
Part 1 Schedule B - BMS-986158 2 mgProgression Free Survival Rate (PFSR)48 weeks25.0 Percent of participants
Part 1 Schedule B - BMS-986158 2 mgProgression Free Survival Rate (PFSR)12 weeks50.0 Percent of participants
Part 1 Schedule B - BMS-986158 2 mgProgression Free Survival Rate (PFSR)24 weeks50.0 Percent of participants
Part 1 Schedule B - BMS-986158 3 mgProgression Free Survival Rate (PFSR)12 weeks33.3 Percent of participants
Part 1 Schedule B - BMS-986158 3 mgProgression Free Survival Rate (PFSR)24 weeks33.3 Percent of participants
Part 1 Schedule B - BMS-986158 3 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule C - BMS-986158 2 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 1 Schedule C - BMS-986158 2 mgProgression Free Survival Rate (PFSR)24 weeks0.0 Percent of participants
Part 1 Schedule C - BMS-986158 2 mgProgression Free Survival Rate (PFSR)12 weeks20.0 Percent of participants
Part 1 Schedule C - BMS-986158 3 mgProgression Free Survival Rate (PFSR)48 weeks9.2 Percent of participants
Part 1 Schedule C - BMS-986158 3 mgProgression Free Survival Rate (PFSR)12 weeks27.5 Percent of participants
Part 1 Schedule C - BMS-986158 3 mgProgression Free Survival Rate (PFSR)24 weeks18.3 Percent of participants
Part 1 Schedule C - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)24 weeks0.0 Percent of participants
Part 1 Schedule C - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)12 weeks45.7 Percent of participants
Part 1 Schedule C - BMS-986158 4.5 mgProgression Free Survival Rate (PFSR)48 weeks0.0 Percent of participants
Part 2 Schedule AProgression Free Survival Rate (PFSR)24 weeks100.0 Percent of participants
Part 2 Schedule AProgression Free Survival Rate (PFSR)12 weeks100.0 Percent of participants
Part 2 Schedule AProgression Free Survival Rate (PFSR)48 weeks100.0 Percent of participants
Secondary

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration

Time frame: Cycle 1 Day 1

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.177 Ratio
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.131 RatioStandard Deviation 0.0426
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.120 RatioStandard Deviation 0.0286
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.158 RatioStandard Deviation 0.0307
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.164 RatioStandard Deviation 0.0809
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.080 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.106 Ratio
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.139 RatioStandard Deviation 0.0401
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.103 RatioStandard Deviation 0.0357
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration0.184 RatioStandard Deviation 0.0947
Secondary

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.154 RatioStandard Deviation 0.0504
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.247 RatioStandard Deviation 0.1
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.141 RatioStandard Deviation 0.0248
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.127 RatioStandard Deviation 0.0369
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.150 RatioStandard Deviation 0.0377
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.125 RatioStandard Deviation 0.0262
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.152 RatioStandard Deviation 0.0572
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.234 RatioStandard Deviation 0.0787
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.233 RatioStandard Deviation 0.0558
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.151 RatioStandard Deviation 0.0558
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.158 Ratio
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.081 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.099 RatioStandard Deviation 0.0279
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.216 Ratio
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.274 RatioStandard Deviation 0.1184
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.182 RatioStandard Deviation 0.0632
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.203 RatioStandard Deviation 0.0788
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.114 RatioStandard Deviation 0.0473
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationCycle 1 Day 10.170 RatioStandard Deviation 0.0821
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose AdministrationLatest timepoint0.320 RatioStandard Deviation 0.1552
Secondary

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.099 RatioStandard Deviation 0.029
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.213 RatioStandard Deviation 0.0786
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.130 Ratio
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.081 RatioStandard Deviation 0.0055
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.086 RatioStandard Deviation 0.0208
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.097 RatioStandard Deviation 0.0425
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.192 RatioStandard Deviation 0.0697
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.187 RatioStandard Deviation 0.0475
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.087 RatioStandard Deviation 0.0347
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.147 Ratio
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.081 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.192 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.066 RatioStandard Deviation 0.0221
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.102 RatioStandard Deviation 0.0178
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.218 RatioStandard Deviation 0.077
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.080 RatioStandard Deviation 0.0283
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.160 RatioStandard Deviation 0.0561
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationLatest timepoint0.253 RatioStandard Deviation 0.1151
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose AdministrationCycle 1 Day 10.108 RatioStandard Deviation 0.0445
Secondary

Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.073 RatioStandard Deviation 0.0104
Part 1 Schedule A - BMS-986158 0.75 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.179 RatioStandard Deviation 0.0726
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.057 RatioStandard Deviation 0.0052
Part 1 Schedule A - BMS-986158 1.25 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.112 RatioStandard Deviation 0.0329
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.068 RatioStandard Deviation 0.0204
Part 1 Schedule A - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.115 RatioStandard Deviation 0.029
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.078 RatioStandard Deviation 0.0268
Part 1 Schedule A - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.144 RatioStandard Deviation 0.0528
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.142 RatioStandard Deviation 0.026
Part 1 Schedule A - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.068 RatioStandard Deviation 0.0303
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.117 Ratio
Part 1 Schedule B - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.066 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.149 Ratio
Part 1 Schedule B - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.059 RatioStandard Deviation 0.0247
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.077 RatioStandard Deviation 0.0373
Part 1 Schedule C - BMS-986158 2 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.163 RatioStandard Deviation 0.0536
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.056 RatioStandard Deviation 0.0187
Part 1 Schedule C - BMS-986158 3 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.115 RatioStandard Deviation 0.0371
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationCycle 1 Day 10.083 RatioStandard Deviation 0.0209
Part 1 Schedule C - BMS-986158 4.5 mgRatio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose AdministrationLatest timepoint0.173 RatioStandard Deviation 0.0576
Secondary

Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

Time frame: From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

Population: All treated participants with available measurements

ArmMeasureGroupValue (MEDIAN)
Part 1 Schedule A - BMS-986158 0.75 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationParent BMS-9861584.00 Hours
Part 1 Schedule A - BMS-986158 0.75 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationMetabolite BMT-16148524.0 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationParent BMS-9861581.00 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationMetabolite BMT-1614852.00 Hours
Part 1 Schedule A - BMS-986158 2 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationParent BMS-9861581.04 Hours
Part 1 Schedule A - BMS-986158 2 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationMetabolite BMT-1614856.00 Hours
Part 1 Schedule A - BMS-986158 3 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationMetabolite BMT-1614853.03 Hours
Part 1 Schedule A - BMS-986158 3 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationParent BMS-9861581.02 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationParent BMS-9861582.02 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime of Maximum Observed Plasma Concentration (Tmax) - Single Dose AdministrationMetabolite BMT-1614856.27 Hours
Secondary

Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

Time frame: From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (MEDIAN)
Part 1 Schedule A - BMS-986158 0.75 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 14.00 Hours
Part 1 Schedule A - BMS-986158 0.75 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint3.14 Hours
Part 1 Schedule A - BMS-986158 0.75 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 124.0 Hours
Part 1 Schedule A - BMS-986158 0.75 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint24.0 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint1.50 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11.00 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint4.00 Hours
Part 1 Schedule A - BMS-986158 1.25 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 12.00 Hours
Part 1 Schedule A - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint2.00 Hours
Part 1 Schedule A - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12.00 Hours
Part 1 Schedule A - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 15.08 Hours
Part 1 Schedule A - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2.07 Hours
Part 1 Schedule A - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12.00 Hours
Part 1 Schedule A - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint2.01 Hours
Part 1 Schedule A - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 123.9 Hours
Part 1 Schedule A - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint2.01 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 115.1 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint2.00 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint4.00 Hours
Part 1 Schedule A - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12.04 Hours
Part 1 Schedule B - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 11.00 Hours
Part 1 Schedule B - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint1.00 Hours
Part 1 Schedule B - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11.00 Hours
Part 1 Schedule B - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1.00 Hours
Part 1 Schedule B - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint1.00 Hours
Part 1 Schedule B - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 11.52 Hours
Part 1 Schedule B - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint1.00 Hours
Part 1 Schedule B - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11.03 Hours
Part 1 Schedule C - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11.00 Hours
Part 1 Schedule C - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint4.08 Hours
Part 1 Schedule C - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint1.00 Hours
Part 1 Schedule C - BMS-986158 2 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 114.9 Hours
Part 1 Schedule C - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint4.00 Hours
Part 1 Schedule C - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 11.00 Hours
Part 1 Schedule C - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 12.02 Hours
Part 1 Schedule C - BMS-986158 3 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint1.66 Hours
Part 1 Schedule C - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 - Cycle 1 Day 16.27 Hours
Part 1 Schedule C - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Cycle 1 day 12.02 Hours
Part 1 Schedule C - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationMetabolite BMT-161485 -Latest timepoint4.00 Hours
Part 1 Schedule C - BMS-986158 4.5 mgTime to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose AdministrationParent BMS-986158 - Latest timepoint2.00 Hours
Secondary

Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for the first and last collection

Time frame: From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)

Population: All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part 1 Schedule A - BMS-986158 0.75 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection35.7 ng/mLGeometric Coefficient of Variation 25
Part 1 Schedule A - BMS-986158 0.75 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection87.9 ng/mLGeometric Coefficient of Variation 63
Part 1 Schedule A - BMS-986158 0.75 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection7.78 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 0.75 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection25.8 ng/mLGeometric Coefficient of Variation 82
Part 1 Schedule A - BMS-986158 1.25 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection9.42 ng/mLGeometric Coefficient of Variation 19
Part 1 Schedule A - BMS-986158 1.25 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection79.6 ng/mLGeometric Coefficient of Variation 10
Part 1 Schedule A - BMS-986158 1.25 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection116 ng/mL
Part 1 Schedule A - BMS-986158 1.25 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection20.1 ng/mL
Part 1 Schedule A - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection11.4 ng/mLGeometric Coefficient of Variation 51
Part 1 Schedule A - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection142 ng/mLGeometric Coefficient of Variation 51
Part 1 Schedule A - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection138 ng/mLGeometric Coefficient of Variation 48
Part 1 Schedule A - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection65.8 ng/mLGeometric Coefficient of Variation 63
Part 1 Schedule A - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection22.2 ng/mLGeometric Coefficient of Variation 48
Part 1 Schedule A - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection280 ng/mLGeometric Coefficient of Variation 64
Part 1 Schedule A - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection257 ng/mLGeometric Coefficient of Variation 27
Part 1 Schedule A - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection461 ng/mLGeometric Coefficient of Variation 36
Part 1 Schedule A - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection36.5 ng/mLGeometric Coefficient of Variation 44
Part 1 Schedule A - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection108 ng/mLGeometric Coefficient of Variation 47
Part 1 Schedule B - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection16.9 ng/mL
Part 1 Schedule B - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection289 ng/mL
Part 1 Schedule B - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection109 ng/mL
Part 1 Schedule B - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection36.4 ng/mL
Part 1 Schedule B - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection79.5 ng/mL
Part 1 Schedule B - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection435 ng/mL
Part 1 Schedule C - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection242 ng/mLGeometric Coefficient of Variation 58
Part 1 Schedule C - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection51.2 ng/mLGeometric Coefficient of Variation 68
Part 1 Schedule C - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection69.1 ng/mL
Part 1 Schedule C - BMS-986158 2 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection10.8 ng/mL
Part 1 Schedule C - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection49.4 ng/mLGeometric Coefficient of Variation 81
Part 1 Schedule C - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 -Last collection370 ng/mL
Part 1 Schedule C - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - Last collection24.5 ng/mL
Part 1 Schedule C - BMS-986158 3 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection282 ng/mLGeometric Coefficient of Variation 98
Part 1 Schedule C - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationParent BMS-986158 - First collection284 ng/mLGeometric Coefficient of Variation 119
Part 1 Schedule C - BMS-986158 4.5 mgTrough Observed Plasma Concentration (Ctrough) - Multiple Dose AdministrationMetabolite BMT-161485 - First collection75.3 ng/mLGeometric Coefficient of Variation 110

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026