Acute Coronary SyndromesPhase 1NCT02089061
Drug Interaction Statin
A Phase 1 study testing BMS-919373, Rosuvastatin and Atorvastatin in people with Acute Coronary Syndromes, run by Bristol-Myers Squibb.
Trial summary
This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- BMS-919373, Rosuvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Written Informed Consent form
- Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Men and women, ages 18 to 55 yrs, inclusive
Who cannot join
- Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure
- Current or history of symptomatic hypotension
- Current or history of liver diseases, including cirrhosis and liver failure
- Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis
- Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator
- History of significant head injury in the last 2 years
About this study
Official title: A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects
This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.
Read the detailed description
Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects
- Conditions
- Acute Coronary Syndromes
- Being tested
- BMS-919373, Rosuvastatin, Atorvastatin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-919373Drug
Also called IKur Inhibitor
RosuvastatinDrug
Also called Crestor®
AtorvastatinDrug
Also called Lipitor®
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Rosuvastatin + BMS-919373 | Experimental | Rosuvastatin 10 mg tablet orally once for Day 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension Receives: Drug: BMS-919373; Drug: Rosuvastatin |
| Cohort 2: Atorvastatin + BMS-919373 | Experimental | Atorvastatin 40 mg tablet once for Days 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension Receives: Drug: BMS-919373; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin
Measured: 26 timepoints up to day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Secondary outcomes (4)
Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin
Measured: 28 timepoints up to day 10
Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation
Adverse Event (AE)
Serious Adverse Event (SAE)
Measured: Up to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT02089061
- Sponsor's protocol ID
- CV205-029
- Status last verified
- Aug 2014
- First submitted
- 14 Mar 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02089061
- Acronym / sponsor ID
- CV205-029
- Conditions
- Acute Coronary Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Mar 2014 (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.
This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.
Detailed description
Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Rosuvastatin + BMS-919373 | Experimental | Drug: BMS-919373, Drug: RosuvastatinRosuvastatin 10 mg tablet orally once for Day 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension |
| Cohort 2: Atorvastatin + BMS-919373 | Experimental | Drug: BMS-919373, Drug: AtorvastatinAtorvastatin 40 mg tablet once for Days 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Written Informed Consent form
- Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Men and women, ages 18 to 55 yrs, inclusive
Key exclusion criteria (6 listed)
- Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure
- Current or history of symptomatic hypotension
- Current or history of liver diseases, including cirrhosis and liver failure
- Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis
- Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator
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-919373Also: IKur Inhibitor | Drug | Cohort 1: Rosuvastatin + BMS-919373, Cohort 2: Atorvastatin + BMS-919373 |
| RosuvastatinAlso: Crestor® | Drug | Cohort 1: Rosuvastatin + BMS-919373 |
| AtorvastatinAlso: Lipitor® | Drug | Cohort 2: Atorvastatin + BMS-919373 |
Primary outcome
Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin
Time frame: 26 timepoints up to day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
4 secondary outcomes
Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin
Time frame: 28 timepoints up to day 10
Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation
Time frame: Up to day 10
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 15 Aug 2014.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-919373, Rosuvastatin and Atorvastatin in people with Acute Coronary Syndromes, run by Bristol-Myers Squibb.
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 6 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin (time frame: 28 timepoints up to day 10). 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 15 Aug 2014.