ThrombosisPhase 1NCT03197779
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
A Phase 1 study testing BMS-962212 and Aspirin in people with Thrombosis, run by Bristol-Myers Squibb at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- BMS-962212 and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 691 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Nov 2013to 24 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225
Wcct Global, Llc
Cypress, California, 90630
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
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
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
- Thrombosis
- Being tested
- BMS-962212, Aspirin, Placebo
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-962212Drug
Intravenous Infusion administration over 2 hours or 5 days
AspirinDrug
Oral administration
PlaceboOther
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| BMS-962212 Two Hour Administration | Experimental | Intravenous administered over 2 hours of BMS-962212 Receives: Drug: BMS-962212 |
| BMS-962212 5 Day Administration | Experimental | Intravenous administered over 5 days of BMS-962212 Receives: Drug: BMS-962212 |
| BMS-962212 and Aspirin | Experimental | BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin Receives: Drug: BMS-962212; Drug: Aspirin |
| Placebo and Aspirin | Placebo comparator | Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin Receives: Drug: Aspirin; Other: Placebo |
| Placebo | Placebo comparator | Placebo intravenous administration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
measured by incidence
Measured: Up to 8 days
Serious Adverse Events (SAE)
measured by incidence
Measured: Up to 8 days
Discontinuation due to AE
measured by incidence
Measured: Up to 8 days
Death
measured by incidence
Measured: Up to 8 days
AE of clinically significant bleeding
measured by incidence
Measured: Up to 8 days
AE of clinically significant infusion reaction
measured by incidence
Measured: Up to 8 days
AE of clinically significant vital signs
measured by incidence
Measured: Up to 8 days
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
measured by ECG
Measured: Up to 8 days
QRS - The interval from the beginning of the Q wave and the end of the S wave
measured by ECG
Measured: Up to 8 days
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
measured by ECG
Measured: Up to 8 days
24-hour cardiac monitoring
measured by telemetry
Measured: 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
Measured: Up to 8 days
Cystatin-C
measured by serum biomarkers
Measured: Up to 8 days
Neutrophil gelatinase-associated lipocalin (NGAL)
measured by urine biomarkers
Measured: Up to 8 days
Monocyte chemoattractant protein-1 (MCP-1)
measured by urine biomarkers
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start18 Nov 2013
- Primary completion2 Feb 2016
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197779
- Sponsor's protocol ID
- CV001-001
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03197779
- Acronym / sponsor ID
- CV001-001
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2013 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BMS-962212 Two Hour Administration | Experimental | Drug: BMS-962212Intravenous administered over 2 hours of BMS-962212 |
| BMS-962212 5 Day Administration | Experimental | Drug: BMS-962212Intravenous administered over 5 days of BMS-962212 |
| BMS-962212 and Aspirin | Experimental | Drug: BMS-962212, Drug: AspirinBMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin |
| Placebo and Aspirin | Placebo comparator | Drug: Aspirin, Other: PlaceboPlacebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo intravenous administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-962212Intravenous Infusion administration over 2 hours or 5 days | Drug | BMS-962212 5 Day Administration, BMS-962212 Two Hour Administration, BMS-962212 and Aspirin |
| AspirinOral administration | Drug | BMS-962212 and Aspirin, Placebo and Aspirin |
| PlaceboOral administration | Other | Placebo, Placebo and Aspirin |
Primary outcome
Adverse Events (AE)
Time frame: Up to 8 days
measured by incidence
Serious Adverse Events (SAE)
Time frame: Up to 8 days
measured by incidence
Discontinuation due to AE
Time frame: Up to 8 days
measured by incidence
Death
Time frame: Up to 8 days
measured by incidence
AE of clinically significant bleeding
Time frame: Up to 8 days
measured by incidence
AE of clinically significant infusion reaction
Time frame: Up to 8 days
measured by incidence
AE of clinically significant vital signs
Time frame: Up to 8 days
measured by incidence
QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
Time frame: Up to 8 days
measured by ECG
QRS - The interval from the beginning of the Q wave and the end of the S wave
Time frame: Up to 8 days
measured by ECG
PR - The interval from the beginning of the P wave to the beginning of the QRS complex
Time frame: Up to 8 days
measured by ECG
24-hour cardiac monitoring
Time frame: Up to 6 days
measured by telemetry
Glomerular filtration rate (GFR)
Time frame: Up to 8 days
measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation
Cystatin-C
Time frame: Up to 8 days
measured by serum biomarkers
Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Up to 8 days
measured by urine biomarkers
Monocyte chemoattractant protein-1 (MCP-1)
Time frame: Up to 8 days
measured by urine biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-962212 and Aspirin in people with Thrombosis, run by Bristol-Myers Squibb at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: Up to 8 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 3 Nov 2026.