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Completed

NCT Number: NCT04154800

A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.

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Key information

Conditions

Health Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
  • Women and men must agree to follow specific methods of contraception if applicable.
  • Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants

Exclusion criteria

  • Women who are of childbearing potential
  • Women who are breastfeeding
  • Any acute or chronic medical illness
  • History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
  • History of heart disease or conduction disorders
  • Head injury in the last 2 years, intracranial tumor, or aneurysm
  • Known abdominal aneurysm
  • Current or history of rectal bleeding, hematemesis, or hematuria

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986209

Drug

Specified Dose on Specified Days

BMS-986209 Placebo

Other

Specified Dose on Specified Days

Itraconazole

Drug

Specified Dose on Specified Days

Diltiazem

Drug

Specified Dose on Specified Days

Primary outcomes

  1. Incidence of Adverse Events (AEs) including bleeding

    Time frame: Up to 18 days

  2. Incidence of serious AEs (SAEs)

    Time frame: Up to 44 days

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to 18 days

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 18 days

  5. Incidence of clinically significant changes in vital signs: Respiratory Rate

    Time frame: Up to 18 days

  6. Incidence of clinically significant changes in vital signs: Seated blood pressure

    Time frame: Up to 18 days

  7. Incidence of clinically significant changes in vital signs: Resting pulse rate

    Time frame: Up to 18 days

  8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters

    Time frame: Up to 18 days

  9. Incidence of clinically significant changes in clinical laboratory tests: Hematology tests

    Time frame: Up to 16 days

  10. Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests

    Time frame: Up to 16 days

  11. Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests

    Time frame: Up to 16 days

  12. Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests

    Time frame: Up to 16 days

  13. Incidence of clinically significant changes in clinical laboratory tests: Serology tests

    Time frame: Up to 16 days

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986209

    Time frame: Up to 18 days

  2. Time of Maximum observed plasma concentration (Tmax) of BMS-986209

    Time frame: Up to 18 days

  3. Terminal plasma half-life (T-Half) of BMS-986209

    Time frame: Up to 18 days

  4. Incidence of Adverse Events (AEs) including bleeding

    Time frame: Up to 18 days

  5. Incidence of serious AEs (SAEs)

    Time frame: Up to 44 days

  6. Incidence of AEs leading to discontinuation

    Time frame: Up to 18 days

  7. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 18 days

  8. Incidence of clinically significant changes in vital signs: Respiratory Rate

    Time frame: Up to 18 days

  9. Incidence of clinically significant changes in vital signs: Seated blood pressure

    Time frame: Up to 18 days

  10. Incidence of clinically significant changes in vital signs: Resting pulse rate

    Time frame: Up to 18 days

  11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters

    Time frame: Up to 18 days

  12. Incidence of clinically significant changes in clinical laboratory tests: Hematology tests

    Time frame: Up to 16 days

  13. Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests

    Time frame: Up to 16 days

  14. Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests

    Time frame: Up to 16 days

  15. Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests

    Time frame: Up to 16 days

  16. Incidence of clinically significant changes in clinical laboratory tests: Serology tests

    Time frame: Up to 16 days

  17. Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels

    Time frame: Up to 16 days

  18. Percent change from baseline in factor XI (FXI) clotting activity

    Time frame: Up to 16 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Jan 4, 2022

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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