Back to resultsA Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
Primary Purpose
Thrombosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-962212
Aspirin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis
Eligibility 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
Sites / Locations
- Wcct Global, Llc
- California Clinical Trials Medical Group
- Parexel International - Baltimore Epcu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
BMS-962212 Two Hour Administration
BMS-962212 5 Day Administration
BMS-962212 and Aspirin
Placebo and Aspirin
Placebo
Arm Description
Intravenous administered over 2 hours of BMS-962212
Intravenous administered over 5 days of BMS-962212
BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Placebo intravenous administration
Outcomes
Primary Outcome Measures
Adverse Events (AE)
measured by incidence
Serious Adverse Events (SAE)
measured by incidence
Discontinuation due to AE
measured by incidence
Death
measured by incidence
AE of clinically significant bleeding
measured by incidence
AE of clinically significant infusion reaction
measured by incidence
AE of clinically significant vital signs
measured by incidence
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
measured by ECG
QRS - The interval from the beginning of the Q wave and the end of the S wave
measured by ECG
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
measured by ECG
24-hour cardiac monitoring
measured by telemetry
Glomerular filtration rate (GFR)
measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation
Cystatin-C
measured by serum biomarkers
Neutrophil gelatinase-associated lipocalin (NGAL)
measured by urine biomarkers
Monocyte chemoattractant protein-1 (MCP-1)
measured by urine biomarkers
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03197779
Brief Title
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 18, 2013 (Actual)
Primary Completion Date
February 2, 2016 (Actual)
Study Completion Date
January 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
691 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-962212 Two Hour Administration
Arm Type
Experimental
Arm Description
Intravenous administered over 2 hours of BMS-962212
Arm Title
BMS-962212 5 Day Administration
Arm Type
Experimental
Arm Description
Intravenous administered over 5 days of BMS-962212
Arm Title
BMS-962212 and Aspirin
Arm Type
Experimental
Arm Description
BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Arm Title
Placebo and Aspirin
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous administration
Intervention Type
Drug
Intervention Name(s)
BMS-962212
Intervention Description
Intravenous Infusion administration over 2 hours or 5 days
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Oral administration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Adverse Events (AE)
Description
measured by incidence
Time Frame
Up to 8 days
Title
Serious Adverse Events (SAE)
Description
measured by incidence
Time Frame
Up to 8 days
Title
Discontinuation due to AE
Description
measured by incidence
Time Frame
Up to 8 days
Title
Death
Description
measured by incidence
Time Frame
Up to 8 days
Title
AE of clinically significant bleeding
Description
measured by incidence
Time Frame
Up to 8 days
Title
AE of clinically significant infusion reaction
Description
measured by incidence
Time Frame
Up to 8 days
Title
AE of clinically significant vital signs
Description
measured by incidence
Time Frame
Up to 8 days
Title
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
Description
measured by ECG
Time Frame
Up to 8 days
Title
QRS - The interval from the beginning of the Q wave and the end of the S wave
Description
measured by ECG
Time Frame
Up to 8 days
Title
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
Description
measured by ECG
Time Frame
Up to 8 days
Title
24-hour cardiac monitoring
Description
measured by telemetry
Time Frame
Up to 6 days
Title
Glomerular filtration rate (GFR)
Description
measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation
Time Frame
Up to 8 days
Title
Cystatin-C
Description
measured by serum biomarkers
Time Frame
Up to 8 days
Title
Neutrophil gelatinase-associated lipocalin (NGAL)
Description
measured by urine biomarkers
Time Frame
Up to 8 days
Title
Monocyte chemoattractant protein-1 (MCP-1)
Description
measured by urine biomarkers
Time Frame
Up to 8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Wcct Global, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Parexel International - Baltimore Epcu
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
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