AtherosclerosisPhase 1NCT01082562
Safety Study of BMS-844421 for Treatment of Hypercholesterolemia
A Phase 1 study testing BMS-844421 and 0.9% sodium chloride injection solution in people with Atherosclerosis and Hypercholesterolemia, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Hypercholesterolemia
- What is being tested?
- BMS-844421 and 0.9% sodium chloride injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Jul 2010
- 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 (SAD)
- Healthy Subjects (MAD) with untreated elevated cholesterol
- Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
- Women who are not of childbearing potential and men, ages 18 to 45
Who cannot join
- Any significant acute or chronic medical illness
- History of liver or renal disorders
- Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol
The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Being tested
- BMS-844421, 0.9% sodium chloride injection solution
- Medical subject headings
- Atherosclerosis, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-844421Drug
Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
0.9% sodium chloride injection solutionDrug
Injection solution, Subcutaneous, 37.5 mg
SAD: Once, 1 Day
MAD: IV loading followed by 4 weekly doses, 29 Days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 2 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 3 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 4 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 5 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 6 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 7 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 8 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 9 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 10 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 11 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 12 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 13 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 14 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
| Arm 15 - BMS-844421 | Experimental | Not described Receives: Drug: BMS-844421 |
| Arm 16 - 0.9% sodium chloride injection solution | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations
Measured: At the conclusion of the MAD part of the study
Secondary outcomes (3)
Assess single and multiple dose pharmacokinetics of BMS-844421
Measured: All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the absolute bioavailability of single BMS-844421 SC doses
Measured: All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the effects of multiple doses of BMS-844421on lipid components
Measured: All outcomes will be assessed at the conclusion of the MAD part of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082562
- Sponsor's protocol ID
- CV198-002
- Other IDs
- 2009-012032-32, 2009
- Status last verified
- Jan 2011
- First submitted
- 5 Mar 2010
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol
- ClinicalTrials.gov ID
- NCT01082562
- Acronym / sponsor ID
- CV198-002
- Conditions
- Atherosclerosis, Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Mar 2010 (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.
The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 2 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 3 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 4 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 5 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 6 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 7 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 8 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 9 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 10 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 11 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 12 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 13 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 14 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
| Arm 15 - BMS-844421 | Experimental | Drug: BMS-844421 |
| Arm 16 - 0.9% sodium chloride injection solution | Placebo comparator | Drug: 0.9% sodium chloride injection solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Subjects (SAD)
- Healthy Subjects (MAD) with untreated elevated cholesterol
- Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
- Women who are not of childbearing potential and men, ages 18 to 45
Key exclusion criteria (3 listed)
- Any significant acute or chronic medical illness
- History of liver or renal disorders
- Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration
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-844421Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days | Drug | Arm 1 - BMS-844421, Arm 11 - BMS-844421, Arm 13 - BMS-844421, Arm 15 - BMS-844421, Arm 3 - BMS-844421, Arm 5 - BMS-844421, Arm 7 - BMS-844421, Arm 9 - BMS-844421 |
| 0.9% sodium chloride injection solutionInjection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days | Drug | Arm 10 - 0.9% sodium chloride injection solution, Arm 12 - 0.9% sodium chloride injection solution, Arm 14 - 0.9% sodium chloride injection solution, Arm 16 - 0.9% sodium chloride injection solution, Arm 2 - 0.9% sodium chloride injection solution, Arm 4 - 0.9% sodium chloride injection solution, Arm 6 - 0.9% sodium chloride injection solution, Arm 8 - 0.9% sodium chloride injection solution |
Primary outcome
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations
Time frame: At the conclusion of the MAD part of the study
3 secondary outcomes
Assess single and multiple dose pharmacokinetics of BMS-844421
Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the absolute bioavailability of single BMS-844421 SC doses
Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the effects of multiple doses of BMS-844421on lipid components
Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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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-844421 and 0.9% sodium chloride injection solution in people with Atherosclerosis and Hypercholesterolemia, run by Bristol-Myers Squibb at 1 site in Germany.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Jan 2011. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations (time frame: At the conclusion of the MAD part of the study). 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 26 Jan 2011; AzTrials last refreshed its copy on 8 Nov 2026.