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Completed

NCT Number: NCT02341638

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

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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials, Llc, Cypress, California, United States

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About this study

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986141

Drug

Placebo

Drug

Aspirin

Drug

Itraconazole

Drug

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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 outcomes

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

    Time frame: Up to Day 14

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

    Time frame: Up to Day 14

  3. 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

  4. 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

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

    Time frame: Up to Day 14

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

    Time frame: Up to Day 14

  7. 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

  8. 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

  9. 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

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

    Time frame: Up to Day 14

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

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

    Time frame: Up to Day 14

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

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

    Time frame: Up to Day 14

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

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

    Time frame: Up to Day 14

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

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

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

    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.

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

    Time frame: 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

  16. Safety of BMS-986141 and itraconazole in healthy subjects

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

    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

  17. Tolerability of BMS-986141 and itraconazole in healthy subjects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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