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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197779
• Other study ID #: CV001-001
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2017
• Last updated: June 28, 2017
• Start date: November 18, 2013
• Est. completion date: January 24, 2017

Study information

• Verified date: June 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: January 24, 2017
• Est. primary completion date: February 2, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-962212
Intravenous Infusion administration over 2 hours or 5 days
• Aspirin
Oral administration

Other:
• Placebo
Oral administration

Locations

Country	Name	City	State
United States	Parexel International - Baltimore Epcu	Baltimore	Maryland
United States	Wcct Global, Llc	Cypress	California
United States	California Clinical Trials Medical Group	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form