AtherosclerosisPhase 1NCT01587365
Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
A Phase 1 study testing BMS-962476 in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
To obtain safety and tolerability information in healthy subjects is administered as a single dose Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- BMS-962476
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy population
- Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL
- Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive
- Men and women, ages 18 to 65 years, inclusive
- Statin population
- Patients with hypercholesterolemia on stable statin therapy for 6 weeks prior to enrollment
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- At enrollment, LDL-c ≥ 100mg/dL and triglycerides ≤ 200 mg/dL
- Patients with controlled hypertension on a stable dose of no more than two antihypertensive drugs
- BMI of 18 to 37 kg/m2 inclusive
- Men and women, ages 18 to 75 years inclusive
Who cannot join
- Healthy Population
- Subjects with fasting LDL-c < 130 or > 190 mg/dL, or fasting triglycerides > 200 mg/dL
- Subjects at increased 10-year cardiovascular risk of ≥ 20% based on Framingham risk score
- Subjects with any significant acute or chronic medical illness at the time of screening, including history of cancer, known history of sickle cell disease or trait, and known history of thalassemia
- Statin population
- Patients with fasting LDL-c < 100mg/dL, or fasting triglycerides > 200 mg/dL on statin therapy
Show all 14Show fewer
- Patients on prescription or over the counter lipid-lowering therapy other than statin therapy
- Patients with established atherosclerotic vascular disease
- Patients with diabetes who are requiring oral or injectable anti-diabetic drug therapy
- Patients with uncontrolled hypertension or controlled hypertension requiring more than two antihypertensive drugs
- Patients with any significant acute or chronic medical illness that is severe, progressive or uncontrolled at the time of screening
- Use of any lipid lowering medication including over the counter products (eg, niacin > 500 mg; omega-3 fatty acids > 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
- Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
- Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Metabolic And Atherosclerosis Research Center/ Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-962476 in Healthy Subjects and in Patients With Hypercholesterolemia on Statin Therapy
To obtain safety and tolerability information in healthy subjects is administered as a single dose
Read the detailed description
- Study Classification: Pharmacokinetics and Pharmacodynamics
- Intervention Model: Single Ascending Dose (SAD) study
- Allocation: Randomized Non-Stratified
- Conditions
- Atherosclerosis
- Being tested
- BMS-962476, Placebo matching with BMS-962476
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-962476Biological
Placebo matching with BMS-962476Biological
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo | Experimental | BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo | Experimental | BMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo | Experimental | BMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
| Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day Receives: Biological: BMS-962476; Biological: Placebo matching with BMS-962476 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs
Measured: Up to Day 43
Secondary outcomes (12)
Pharmacodynamic effects of single subcutaneous (SC) and intravenous (IV) doses of BMS-962476
Pharmacodynamic effects will be measured by fasting lipid panel
Measured: Up to Day 43
Maximum observed plasma concentration (Cmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Measured: 17 time points up to Day 43
Time of maximum observed plasma concentration (Tmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Measured: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC(0-T)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Measured: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Measured: 17 time points up to Day 43
Plasma elimination half-life (T-HALF) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Measured: 17 time points up to Day 43
Total body clearance (CL/F) of BMS-962476 SC Dosing
Measured: 15 time points up to Day 43
Total body clearance (CL) of BMS-962476 IV Dosing
Measured: 17 time points up to Day 43
Volume of distribution at steady state (Vss/F) of BMS-962476 SC Dosing
Measured: 15 time points up to Day 43
Volume of distribution at steady state (Vss) of BMS-962476 IV Dosing
Measured: 15 time points up to Day 43
Absolute bioavailability (F) of total and free BMS-962476
Measured: 15 time points up to Day 43
Frequency of anti-BMS-962476 antibodies (immunogenicity) following single SC and IV doses of BMS-962476
Measured: Up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT01587365
- Sponsor's protocol ID
- CV206-001
- Status last verified
- Sep 2013
- First submitted
- 26 Apr 2012
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-962476 in Healthy Subjects and in Patients With Hypercholesterolemia on Statin Therapy
- ClinicalTrials.gov ID
- NCT01587365
- Acronym / sponsor ID
- CV206-001
- Conditions
- Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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.
To obtain safety and tolerability information in healthy subjects is administered as a single dose
Detailed description
- Study Classification: Pharmacokinetics and Pharmacodynamics
- Intervention Model: Single Ascending Dose (SAD) study
- Allocation: Randomized Non-Stratified
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
| Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
| Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
| Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | Biological: BMS-962476, Biological: Placebo matching with BMS-962476BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy population
- Statin population
Key exclusion criteria (14 listed)
- Healthy Population
- Statin population
- Use of any lipid lowering medication including over the counter products (eg, niacin > 500 mg; omega-3 fatty acids > 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
- Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
- Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids
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-962476 | Biological | Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo, Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo, Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo, Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo, Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo, Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo, Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo, Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo |
| Placebo matching with BMS-962476 | Biological | Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo, Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo, Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo, Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo, Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo, Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo, Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo, Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo |
Primary outcome
Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs
Time frame: Up to Day 43
12 secondary outcomes
Pharmacodynamic effects of single subcutaneous (SC) and intravenous (IV) doses of BMS-962476
Time frame: Up to Day 43
Maximum observed plasma concentration (Cmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Time of maximum observed plasma concentration (Tmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC(0-T)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Plasma elimination half-life (T-HALF) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
Time frame: 17 time points up to Day 43
Total body clearance (CL/F) of BMS-962476 SC Dosing
Time frame: 15 time points up to Day 43
Total body clearance (CL) of BMS-962476 IV Dosing
Time frame: 17 time points up to Day 43
Volume of distribution at steady state (Vss/F) of BMS-962476 SC Dosing
Time frame: 15 time points up to Day 43
Volume of distribution at steady state (Vss) of BMS-962476 IV Dosing
Time frame: 15 time points up to Day 43
Absolute bioavailability (F) of total and free BMS-962476
Time frame: 15 time points up to Day 43
Frequency of anti-BMS-962476 antibodies (immunogenicity) following single SC and IV doses of BMS-962476
Time frame: Up to Day 43
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 4 Sep 2013.
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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
1 site 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-962476 in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site 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 10 inclusion and 14 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs (time frame: Up to Day 43). 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 4 Sep 2013.