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Completed

NCT Number: NCT03197779

A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wcct Global, Llc, Cypress, California, United States

Loading trial locations.

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 subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations
  • Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive [as calculated by BMI = weight (kg)/ [height (m)]2
  • This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be re-consented
  • Men, ages 18 to 45 years, inclusive; women, ages 18-45, who are not of child-bearing potential
  • Women must not be breastfeeding

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Women of child-bearing potential
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease which by the judgment of the Investigator may increase a subject's risk of gastrointestinal bleeding (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrectomy)
  • Any major surgery within 12 weeks of study drug administration
  • History of blood transfusion, clinically significant bleeding event(s), or documented genetic bleeding diathesis or thrombophilia
  • For Aspirin Containing Arm Participants Only: Known allergy to non-steroidal anti-inflammatory drugs or history of intolerance or abnormal sensitivity to aspirin (e.g gastrointestinal intolerance, bruising or bleeding, aspirin induced breathing difficulties or nasal polyps)

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-962212

Drug

Intravenous Infusion administration over 2 hours or 5 days

Aspirin

Drug

Oral administration

Placebo

Other

Oral administration

Primary outcomes

  1. Adverse Events (AE)

    Time frame: Up to 8 days

    measured by incidence

  2. Serious Adverse Events (SAE)

    Time frame: Up to 8 days

    measured by incidence

  3. Discontinuation due to AE

    Time frame: Up to 8 days

    measured by incidence

  4. Death

    Time frame: Up to 8 days

    measured by incidence

  5. AE of clinically significant bleeding

    Time frame: Up to 8 days

    measured by incidence

  6. AE of clinically significant infusion reaction

    Time frame: Up to 8 days

    measured by incidence

  7. AE of clinically significant vital signs

    Time frame: Up to 8 days

    measured by incidence

  8. QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula

    Time frame: Up to 8 days

    measured by ECG

  9. QRS - The interval from the beginning of the Q wave and the end of the S wave

    Time frame: Up to 8 days

    measured by ECG

  10. PR - The interval from the beginning of the P wave to the beginning of the QRS complex

    Time frame: Up to 8 days

    measured by ECG

  11. 24-hour cardiac monitoring

    Time frame: Up to 6 days

    measured by telemetry

  12. Glomerular filtration rate (GFR)

    Time frame: Up to 8 days

    measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation

  13. Cystatin-C

    Time frame: Up to 8 days

    measured by serum biomarkers

  14. Neutrophil gelatinase-associated lipocalin (NGAL)

    Time frame: Up to 8 days

    measured by urine biomarkers

  15. Monocyte chemoattractant protein-1 (MCP-1)

    Time frame: Up to 8 days

    measured by urine biomarkers

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS- 962212 in Healthy Subjects

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 23, 2017
Registry last updated
Jul 2, 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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