Clinical Trials/NCT02341638

NCT02341638

Completed

Phase 1

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

Bristol-Myers Squibb2 sites in 1 country148 target enrollmentSeptember 2014

ConditionsThrombosis

InterventionsPlacebo BMS-986141 Aspirin Itraconazole

DrugsBMS-986141 Placebo Aspirin Itraconazole

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Thrombosis
Sponsor: Bristol-Myers Squibb
Enrollment: 148
Locations: 2
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Part C Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part A Panel 4: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 4: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 5: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 5: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 6: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 6: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Intervention: Placebo

Part A Panel 7: BMS-986141

Single dose by mouth as specified

Intervention: BMS-986141

Part A Panel 8: BMS-986141

Single dose by mouth as specified

Intervention: BMS-986141

Part B Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part B Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part B Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part B Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part B Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part B Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part C Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part C Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part C Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part C Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: BMS-986141

Part C Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Intervention: Placebo

Part D Panel 1: BMS-986141 and Aspirin

BMS-986141 and Aspirin by mouth as specified

Intervention: BMS-986141

Part D Panel 1: BMS-986141 and Aspirin

BMS-986141 and Aspirin by mouth as specified

Intervention: Aspirin

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

BMS-986141 placebo and Aspirin by mouth as specified

Intervention: Placebo

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

BMS-986141 placebo and Aspirin by mouth as specified

Intervention: Aspirin

Part E Panel 1: BMS-986141 and Itraconazole

BMS-986141 and Itraconazole by mouth as specified

Intervention: BMS-986141

Part E Panel 1: BMS-986141 and Itraconazole

BMS-986141 and Itraconazole by mouth as specified

Intervention: Itraconazole

Outcomes

Primary Outcomes

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

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

Time Frame: 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

Time Frame: 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

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

Secondary Outcomes

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)
MR_Cmax of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
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(Up to Day 14)
Safety of multiple doses of BMS-986141 and aspirin in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
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(Up to Day 14)
MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Tolerability of BMS-986141 and itraconazole in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
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)
Safety of BMS-986141 and itraconazole in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)

Study Sites (2)

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