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

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: BMS-962212; Other: Placebo; Drug: Aspirin

• Registration Number: NCT03197779
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Primary Completion: 2016-02-02
• Study Completion: 2017-01-24
• Status Verified: 2017-06
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Aspirin	Placebo	Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Placebo	Placebo	Placebo intravenous administration
BMS-962212 Two Hour Administration	BMS-962212	Intravenous administered over 2 hours of BMS-962212
BMS-962212 5 Day Administration	BMS-962212	Intravenous administered over 5 days of BMS-962212
BMS-962212 and Aspirin	BMS-962212	BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
BMS-962212 and Aspirin	Aspirin	BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Placebo and Aspirin	Aspirin	Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE)	Up to 8 days	measured by incidence
AE of clinically significant bleeding	Up to 8 days	measured by incidence
Serious Adverse Events (SAE)	Up to 8 days	measured by incidence
QRS - The interval from the beginning of the Q wave and the end of the S wave	Up to 8 days	measured by ECG
Discontinuation due to AE	Up to 8 days	measured by incidence
Death	Up to 8 days	measured by incidence
AE of clinically significant infusion reaction	Up to 8 days	measured by incidence
AE of clinically significant vital signs	Up to 8 days	measured by incidence
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula	Up to 8 days	measured by ECG
Cystatin-C	Up to 8 days	measured by serum biomarkers
Neutrophil gelatinase-associated lipocalin (NGAL)	Up to 8 days	measured by urine biomarkers
Glomerular filtration rate (GFR)	Up to 8 days	measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation
PR - The interval from the beginning of the P wave to the beginning of the QRS complex	Up to 8 days	measured by ECG
Monocyte chemoattractant protein-1 (MCP-1)	Up to 8 days	measured by urine biomarkers
24-hour cardiac monitoring	Up to 6 days	measured by telemetry

Trial Locations

Locations (3)

Wcct Global, Llc; 🇺🇸 Cypress, California, United States

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Parexel International - Baltimore Epcu; 🇺🇸 Baltimore, Maryland, United States