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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Aspirin; Other: Placebo; Drug: BMS-962212

Study type: Interventional

Funder types: Industry

Identifiers

NCT03197779

CV001-001

Details and patient eligibility

About

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.

Enrollment: 691 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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691 participants in 5 patient groups, including a placebo group

BMS-962212 Two Hour Administration

Experimental group

Description:

Intravenous administered over 2 hours of BMS-962212

Treatment:

Drug: BMS-962212

BMS-962212 5 Day Administration

Experimental group

Description:

Intravenous administered over 5 days of BMS-962212

Treatment:

Drug: BMS-962212

BMS-962212 and Aspirin

Experimental group

Description:

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

Treatment:

Drug: BMS-962212

Drug: Aspirin

Placebo and Aspirin

Placebo Comparator group

Description:

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

Treatment:

Drug: Aspirin

Other: Placebo

Placebo

Placebo Comparator group

Description:

Placebo intravenous administration

Treatment:

Other: Placebo