HypercholesterolemiaPhase 1NCT01651273
A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
A Phase 1 study testing BMS-852927 in people with Hypercholesterolemia, run by Bristol-Myers Squibb at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- BMS-852927
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Nov 2012to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, aged ≥18 to ≤75
- Body mass index (BMI) ≤ 40 kg/m2
- Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
- Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)
Who cannot join
- Any significant acute medical illness, significant cardiovascular history
- Current or history of hepatic or hepatobiliary disease
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada6 sites
Local Institution
Brampton, Ontario, L6T 0G1
Local Institution
Pointe-Claire, Quebec, H9R 4S3
Local Institution
Québec, Quebec, G1N 4V3
Local Institution
Québec, Quebec, G3K 2P8
Local Institution
Toronto, Ontario, M4G 3E8
Local Institution
Victoriaville, Quebec, G6P 6P6
About this study
Official title: A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
- Conditions
- Hypercholesterolemia
- Being tested
- BMS-852927, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-852927Drug
Capsules, Oral, 0.25 mg, Once daily, 28 days
BMS-852927Drug
Capsules, Oral, 1.0 mg, Once daily, 28 days
BMS-852927Drug
Capsules, Oral, 2.5 mg, Once daily, 28 days
PlaceboDrug
Capsules, Oral, 0 mg, Once daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-852927 (0.25 mg) | Experimental | Not described Receives: Drug: BMS-852927 |
| Arm 2: BMS-852927 (1.0 mg) | Experimental | Not described Receives: Drug: BMS-852927 |
| Arm 3: BMS-852927 (2.5 mg) | Experimental | Not described Receives: Drug: BMS-852927 |
| Arm 4: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Measured: Up to 56 days of study participation
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Measured: Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
Number and percent of subjects with potentially clinically significant changes in ECG parameter
Electrocardiogram (ECG) parameters defined as:
- Investigator identified clinically significant abnormalities
- QTcF> 480 msec or QTcF changes from baseline> 60 msec
- QRS (msec): QRS> 120 msec
- PR (msec): PR > 210 msec
Measured: Upto 56 days
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
LDL-c (measured) defined as:
- LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%
Measured: Upto 56 days
Secondary outcomes (2)
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
Measured: Days 7, 14, 21 and 28
Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data
Measured: Days 1 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 97 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
- NCT01651273
- Sponsor's protocol ID
- CV201-008
- Other IDs
- 2012-001946-17
- Status last verified
- Aug 2013
- First submitted
- 13 Jul 2012
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy
- ClinicalTrials.gov ID
- NCT01651273
- Acronym / sponsor ID
- CV201-008
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jul 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.
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-852927 (0.25 mg) | Experimental | Drug: BMS-852927 |
| Arm 2: BMS-852927 (1.0 mg) | Experimental | Drug: BMS-852927 |
| Arm 3: BMS-852927 (2.5 mg) | Experimental | Drug: BMS-852927 |
| Arm 4: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, aged ≥18 to ≤75
- Body mass index (BMI) ≤ 40 kg/m2
- Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
- Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)
Key exclusion criteria (3 listed)
- Any significant acute medical illness, significant cardiovascular history
- Current or history of hepatic or hepatobiliary disease
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
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-852927Capsules, Oral, 0.25 mg, Once daily, 28 days | Drug | Arm 1: BMS-852927 (0.25 mg) |
| BMS-852927Capsules, Oral, 1.0 mg, Once daily, 28 days | Drug | Arm 2: BMS-852927 (1.0 mg) |
| BMS-852927Capsules, Oral, 2.5 mg, Once daily, 28 days | Drug | Arm 3: BMS-852927 (2.5 mg) |
| PlaceboCapsules, Oral, 0 mg, Once daily, 28 days | Drug | Arm 4: Placebo |
Primary outcome
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Time frame: Up to 56 days of study participation
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
Number and percent of subjects with potentially clinically significant changes in ECG parameter
Time frame: Upto 56 days
Electrocardiogram (ECG) parameters defined as: * Investigator identified clinically significant abnormalities * QTcF> 480 msec or QTcF changes from baseline> 60 msec * QRS (msec): QRS> 120 msec * PR (msec): PR > 210 msec
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
Time frame: Upto 56 days
LDL-c (measured) defined as: * LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%
2 secondary outcomes
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
Time frame: Days 7, 14, 21 and 28
Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data
Time frame: Days 1 and 28
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 5 Aug 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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-852927 in people with Hypercholesterolemia, run by Bristol-Myers Squibb at 8 sites in 2 countries.
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 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, 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?
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy (time frame: Up to 56 days of study participation). The study lists 4 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 5 Aug 2013.