A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
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
1 other identifier
interventional
691
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2013
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2017
CompletedFirst Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedJuly 2, 2017
June 1, 2017
2.2 years
June 21, 2017
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (15)
Adverse Events (AE)
measured by incidence
Up to 8 days
Serious Adverse Events (SAE)
measured by incidence
Up to 8 days
Discontinuation due to AE
measured by incidence
Up to 8 days
Death
measured by incidence
Up to 8 days
AE of clinically significant bleeding
measured by incidence
Up to 8 days
AE of clinically significant infusion reaction
measured by incidence
Up to 8 days
AE of clinically significant vital signs
measured by incidence
Up to 8 days
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
measured by ECG
Up to 8 days
QRS - The interval from the beginning of the Q wave and the end of the S wave
measured by ECG
Up to 8 days
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
measured by ECG
Up to 8 days
24-hour cardiac monitoring
measured by telemetry
Up to 6 days
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
Cystatin-C
measured by serum biomarkers
Up to 8 days
Neutrophil gelatinase-associated lipocalin (NGAL)
measured by urine biomarkers
Up to 8 days
Monocyte chemoattractant protein-1 (MCP-1)
measured by urine biomarkers
Up to 8 days
Study Arms (5)
BMS-962212 Two Hour Administration
EXPERIMENTALIntravenous administered over 2 hours of BMS-962212
BMS-962212 5 Day Administration
EXPERIMENTALIntravenous administered over 5 days of BMS-962212
BMS-962212 and Aspirin
EXPERIMENTALBMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Placebo and Aspirin
PLACEBO COMPARATORPlacebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Placebo
PLACEBO COMPARATORPlacebo intravenous administration
Interventions
Intravenous Infusion administration over 2 hours or 5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Wcct Global, Llc
Cypress, California, 90630, United States
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 23, 2017
Study Start
November 18, 2013
Primary Completion
February 2, 2016
Study Completion
January 24, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06