NCT02341638

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 31, 2017

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

January 14, 2015

Last Update Submit

March 29, 2017

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (4)

  • Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

    Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)

    Up to 30 days post discontinuation of dosing or last participation in the study

  • Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

    Up to 30 days post discontinuation of dosing or last participation in the study

  • Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

    Up to 30 days post discontinuation of dosing or last participation in the study

  • Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

    Up to 30 days post discontinuation of dosing or last participation in the study

Secondary Outcomes (17)

  • Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

    Up to Day 14

  • Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

    Up to Day 14

  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

    Up to Day 14

  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

    Up to Day 14

  • Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

    Up to Day 14

  • +12 more secondary outcomes

Study Arms (17)

Part A Panel 1: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 2: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 3: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 4: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 5: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 6: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo single dose by mouth as specified

Drug: BMS-986141Drug: Placebo

Part A Panel 7: BMS-986141

EXPERIMENTAL

Single dose by mouth as specified

Drug: BMS-986141

Part A Panel 8: BMS-986141

EXPERIMENTAL

Single dose by mouth as specified

Drug: BMS-986141

Part B Panel 1: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part B Panel 2: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part B Panel 3: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part C Panel 1: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part C Panel 2: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part C Panel 3: BMS-986141 or Placebo

EXPERIMENTAL

BMS-986141 or Placebo by mouth as specified

Drug: BMS-986141Drug: Placebo

Part D Panel 1: BMS-986141 and Aspirin

EXPERIMENTAL

BMS-986141 and Aspirin by mouth as specified

Drug: BMS-986141Drug: Aspirin

Part D Panel 1: Placebo matching BMS-986141 and Aspirin

PLACEBO COMPARATOR

BMS-986141 placebo and Aspirin by mouth as specified

Drug: PlaceboDrug: Aspirin

Part E Panel 1: BMS-986141 and Itraconazole

EXPERIMENTAL

BMS-986141 and Itraconazole by mouth as specified

Drug: BMS-986141Drug: Itraconazole

Interventions

BMS-986141DRUG
Part A Panel 1: BMS-986141 or PlaceboPart A Panel 2: BMS-986141 or PlaceboPart A Panel 3: BMS-986141 or PlaceboPart A Panel 4: BMS-986141 or PlaceboPart A Panel 5: BMS-986141 or PlaceboPart A Panel 6: BMS-986141 or PlaceboPart A Panel 7: BMS-986141Part A Panel 8: BMS-986141Part B Panel 1: BMS-986141 or PlaceboPart B Panel 2: BMS-986141 or PlaceboPart B Panel 3: BMS-986141 or PlaceboPart C Panel 1: BMS-986141 or PlaceboPart C Panel 2: BMS-986141 or PlaceboPart C Panel 3: BMS-986141 or PlaceboPart D Panel 1: BMS-986141 and AspirinPart E Panel 1: BMS-986141 and Itraconazole
PlaceboDRUG
Part A Panel 1: BMS-986141 or PlaceboPart A Panel 2: BMS-986141 or PlaceboPart A Panel 3: BMS-986141 or PlaceboPart A Panel 4: BMS-986141 or PlaceboPart A Panel 5: BMS-986141 or PlaceboPart A Panel 6: BMS-986141 or PlaceboPart B Panel 1: BMS-986141 or PlaceboPart B Panel 2: BMS-986141 or PlaceboPart B Panel 3: BMS-986141 or PlaceboPart C Panel 1: BMS-986141 or PlaceboPart C Panel 2: BMS-986141 or PlaceboPart C Panel 3: BMS-986141 or PlaceboPart D Panel 1: Placebo matching BMS-986141 and Aspirin
AspirinDRUG
Part D Panel 1: BMS-986141 and AspirinPart D Panel 1: Placebo matching BMS-986141 and Aspirin
ItraconazoleDRUG
Part E Panel 1: BMS-986141 and Itraconazole

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[height(m)\]2
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

You may not qualify if:

  • Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West Coast Clinical Trials, Llc

Cypress, California, 90630, United States

Location

Ppd Development, Lp

Austin, Texas, 78744, United States

Location

Related Publications (1)

  • Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D. First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants. Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846.

    PMID: 37394920DERIVED

Related Links

MeSH Terms

Conditions

Thrombosis

Interventions

BMS-986141AspirinItraconazole

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 31, 2017

Record last verified: 2015-09

Locations

US(2)