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

Completed · Phase 1 · Has a placebo group

Conditions studied: Thrombosis

In brief

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.

Key facts

Study ID

NCT03197779

Run by

Bristol-Myers Squibb

People needed

691

Starts

2013-11-18

Expected to finish

2017-01-24

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wcct Global, Llc — Cypress, California, United States
• California Clinical Trials Medical Group — Glendale, California, United States
• Parexel International - Baltimore Epcu — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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