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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

691 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-18

Study Completion Date

2017-01-24

Brief Summary

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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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Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BMS-962212 Two Hour Administration

Intravenous administered over 2 hours of BMS-962212

Group Type EXPERIMENTAL

BMS-962212

Intervention Type DRUG

Intravenous Infusion administration over 2 hours or 5 days

BMS-962212 5 Day Administration

Intravenous administered over 5 days of BMS-962212

Group Type EXPERIMENTAL

BMS-962212

Intervention Type DRUG

Intravenous Infusion administration over 2 hours or 5 days

BMS-962212 and Aspirin

BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin

Group Type EXPERIMENTAL

BMS-962212

Intervention Type DRUG

Intravenous Infusion administration over 2 hours or 5 days

Aspirin

Intervention Type DRUG

Oral administration

Placebo and Aspirin

Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin

Group Type PLACEBO_COMPARATOR

Aspirin

Intervention Type DRUG

Oral administration

Placebo

Intervention Type OTHER

Oral administration

Placebo

Placebo intravenous administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral administration

Interventions

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BMS-962212

Intravenous Infusion administration over 2 hours or 5 days

Intervention Type DRUG

Aspirin

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes