Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986141

Placebo

Aspirin

Itraconazole

About this trial

This is an interventional basic science trial for Thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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

Exclusion Criteria:

Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
Other protocol-defined exclusion criteria could apply

Sites / Locations

West Coast Clinical Trials, Llc
Ppd Development, Lp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part A Panel 1: BMS-986141 or Placebo

Part A Panel 2: BMS-986141 or Placebo

Part A Panel 3: BMS-986141 or Placebo

Part A Panel 4: BMS-986141 or Placebo

Part A Panel 5: BMS-986141 or Placebo

Part A Panel 6: BMS-986141 or Placebo

Part A Panel 7: BMS-986141

Part A Panel 8: BMS-986141

Part B Panel 1: BMS-986141 or Placebo

Part B Panel 2: BMS-986141 or Placebo

Part B Panel 3: BMS-986141 or Placebo

Part C Panel 1: BMS-986141 or Placebo

Part C Panel 2: BMS-986141 or Placebo

Part C Panel 3: BMS-986141 or Placebo

Part D Panel 1: BMS-986141 and Aspirin

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

Part E Panel 1: BMS-986141 and Itraconazole

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Single dose by mouth as specified

BMS-986141 or Placebo by mouth as specified

BMS-986141 and Aspirin by mouth as specified

BMS-986141 placebo and Aspirin by mouth as specified

BMS-986141 and Itraconazole by mouth as specified

Outcomes

Primary Outcome Measures

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)

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

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

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

Secondary Outcome Measures

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

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

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

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

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

Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose

Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

MR_Cmax of BMT-162853, BMT-162856, and BMT-181551

Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)

MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551

Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)]

MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551

Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]

MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551

Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]

Safety of multiple doses of BMS-986141 and aspirin in healthy subjects

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.

Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects

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

Safety of BMS-986141 and itraconazole in healthy subjects

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

Tolerability of BMS-986141 and itraconazole in healthy subjects

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

Full Information

NCT ID

NCT02341638

First Posted

January 14, 2015

Last Updated

March 29, 2017

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02341638

Brief Title

Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Official Title

Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

Maximum Age: Part A SAD 65 years Part B MAD 75 years Part C MAD Japanese 75 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A Panel 1: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 2: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 3: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 4: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 5: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 6: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo single dose by mouth as specified

Arm Title

Part A Panel 7: BMS-986141

Arm Type

Experimental

Arm Description

Single dose by mouth as specified

Arm Title

Part A Panel 8: BMS-986141

Arm Type

Experimental

Arm Description

Single dose by mouth as specified

Arm Title

Part B Panel 1: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part B Panel 2: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part B Panel 3: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part C Panel 1: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part C Panel 2: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part C Panel 3: BMS-986141 or Placebo

Arm Type

Experimental

Arm Description

BMS-986141 or Placebo by mouth as specified

Arm Title

Part D Panel 1: BMS-986141 and Aspirin

Arm Type

Experimental

Arm Description

BMS-986141 and Aspirin by mouth as specified

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

BMS-986141 placebo and Aspirin by mouth as specified

Arm Title

Part E Panel 1: BMS-986141 and Itraconazole

Arm Type

Experimental

Arm Description

BMS-986141 and Itraconazole by mouth as specified

Intervention Type

Drug

Intervention Name(s)

BMS-986141

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to Day 14

Title

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

Time Frame

Up to Day 14

Title

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

Time Frame

Up to Day 14

Title

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

Time Frame

Up to Day 14

Title

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

Time Frame

Up to Day 14

Title

Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

Time Frame

Up to Day 14

Title

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

Time Frame

Up to Day 14

Title

AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose

Time Frame

Up to Day 14

Title

Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551

Time Frame

Up to Day 14

Title

MR_Cmax of BMT-162853, BMT-162856, and BMT-181551

Description

Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)

Time Frame

Up to Day 14

Title

MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551

Description

Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)]

Time Frame

Up to Day 14

Title

MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551

Description

Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]

Time Frame

Up to Day 14

Title

MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551

Description

Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]

Time Frame

Up to Day 14

Title

Safety of multiple doses of BMS-986141 and aspirin in healthy subjects

Description

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.

Time Frame

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

Title

Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects

Description

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

Time Frame

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

Title

Safety of BMS-986141 and itraconazole in healthy subjects

Description

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

Time Frame

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

Title

Tolerability of BMS-986141 and itraconazole in healthy subjects

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol Other protocol-defined exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

West Coast Clinical Trials, Llc

City

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

Facility Name

Ppd Development, Lp

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Thrombosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial