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

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ClinicalTrials.gov Identifier: NCT03197779
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: BMS-962212 Drug: Aspirin Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 18, 2013
Actual Primary Completion Date : February 2, 2016
Actual Study Completion Date : January 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: BMS-962212 Two Hour Administration
Intravenous administered over 2 hours of BMS-962212
Drug: BMS-962212
Intravenous Infusion administration over 2 hours or 5 days

Experimental: BMS-962212 5 Day Administration
Intravenous administered over 5 days of BMS-962212
Drug: BMS-962212
Intravenous Infusion administration over 2 hours or 5 days

Experimental: BMS-962212 and Aspirin
BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Drug: BMS-962212
Intravenous Infusion administration over 2 hours or 5 days

Drug: Aspirin
Oral administration

Placebo Comparator: Placebo and Aspirin
Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Drug: Aspirin
Oral administration

Other: Placebo
Oral administration

Placebo Comparator: Placebo
Placebo intravenous administration
Other: Placebo
Oral administration




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197779


Locations
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United States, California
Wcct Global, Llc
Cypress, California, United States, 90630
California Clinical Trials Medical Group
Glendale, California, United States, 91206
United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03197779     History of Changes
Other Study ID Numbers: CV001-001
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics