CompletedNCT03197779Updated Jul 2, 2017

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

A Phase 1 interventional study of BMS-962212 and Aspirin in Thrombosis, sponsored by Bristol-Myers Squibb. Completed at 3 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2016, 10 years 8 months ago, and no results have been posted to the registry.
Registered 3 years 7 months after the study started (first participant enrolled Nov 2013, registered Jun 2017).

Phase: Phase 1
Study type: Interventional
Enrollment: 691
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

Thrombosis

Browse trials for

Thrombosis 1,506

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 691 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 691 participants (actual)

Study arms

Experimental
BMS-962212 Two Hour Administration
Intravenous administered over 2 hours of BMS-962212
Drug: BMS-962212
Experimental
BMS-962212 5 Day Administration
Intravenous administered over 5 days of BMS-962212
Drug: BMS-962212
Experimental
BMS-962212 and Aspirin
BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Drug: BMS-962212 · Drug: Aspirin
Placebo comparator
Placebo and Aspirin
Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
Drug: Aspirin · Other: Placebo
Placebo comparator
Placebo
Placebo intravenous administration
Other: Placebo

Interventions

DrugBMS-962212
Intravenous Infusion administration over 2 hours or 5 days
DrugAspirin
Oral administration
OtherPlacebo
Oral administration

What researchers measure

Primary outcomes

Adverse Events (AE)
measured by incidence
Time frame: Up to 8 days
Serious Adverse Events (SAE)
measured by incidence
Time frame: Up to 8 days
Discontinuation due to AE
measured by incidence
Time frame: Up to 8 days
Death
measured by incidence
Time frame: Up to 8 days
AE of clinically significant bleeding
measured by incidence
Time frame: Up to 8 days
AE of clinically significant infusion reaction
measured by incidence
Time frame: Up to 8 days
AE of clinically significant vital signs
measured by incidence
Time frame: Up to 8 days
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
measured by ECG
Time frame: Up to 8 days
QRS - The interval from the beginning of the Q wave and the end of the S wave
measured by ECG
Time frame: Up to 8 days
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
measured by ECG
Time frame: Up to 8 days
24-hour cardiac monitoring
measured by telemetry
Time frame: 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
Time frame: Up to 8 days
Cystatin-C
measured by serum biomarkers
Time frame: Up to 8 days
Neutrophil gelatinase-associated lipocalin (NGAL)
measured by urine biomarkers
Time frame: Up to 8 days
Monocyte chemoattractant protein-1 (MCP-1)
measured by urine biomarkers
Time frame: Up to 8 days

Study locations

3 sites

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

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03197779
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jun 23, 2017
Start date: Nov 18, 2013
Primary completion: Feb 2, 2016
Completion: Jan 24, 2017
Last update: Jul 2, 2017

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thrombosis→

Other studies from this sponsor