Myocardial FailurePhase 1NCT03332186
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
A Phase 1 study testing BMS-986231 in people with Myocardial Failure and Cardiac Failure, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Failure, Cardiac Failure, Congestive Heart Failure
- What is being tested?
- BMS-986231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Mar 2018to 22 Oct 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight ≥ 45 kg and ≤ 120 kg
- BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
- Heart rate ≥ 50 bpm and < 95 bpm
- Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
- No changes in medication within 30 days prior to study drug administration
Who cannot join
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
- History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal
- History of migraine or cluster headaches
- Patients requiring dialysis will not be enrolled in this study
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Poland2 sites
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, 05-825
Specjalistyczne Centrum Medyczne Panacea Poznan
Krakow, 31-559
About this study
Official title: A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
- Conditions
- Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Kidney Failure, Renal Failure
- Being tested
- BMS-986231
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986231Drug
Intravenous infusion administration
| Study group | Role | What they receive |
|---|---|---|
| Mild Renal Impairment | Experimental | Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2 Receives: Drug: BMS-986231 |
| Moderate renal impairment | Experimental | Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2 Receives: Drug: BMS-986231 |
| Severe renal impairment | Experimental | Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis Receives: Drug: BMS-986231 |
| Normal renal function | Experimental | Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2 Receives: Drug: BMS-986231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) derived from plasma concentration
Measured: 11 days
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
Measured: 11 days
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
Measured: 11 days
Clearance (CL) derived from plasma concentration
Measured: 11 days
Renal clearance (CLR) derived from urine concentration
Measured: 11 days
Secondary outcomes (9)
Number of adverse events (AE)
Measured: Up to 31 days
Number of serious adverse events (SAE)
Measured: Up to 31 days
Terminal elimination half-life (t1/2)
Measured: Up to 36 hours
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 36 hours
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
Measured: Up to 36 hours
Terminal elimination phase rate constant (λz)
Measured: Up to 36 hours
Volume of distribution during terminal phase (Vz)
Measured: Up to 36 hours
Fraction of administered drug excreted into urine (Fe)
Measured: Up to 36 hours
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)
Measured: Up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Mar 2018
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FailureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT03332186
- Sponsor's protocol ID
- CV013-025
- Status last verified
- Sep 2019
- First submitted
- 2 Nov 2017
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT03332186
- Acronym / sponsor ID
- CV013-025
- Conditions
- Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Kidney Failure, Renal Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 6 Nov 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 investigate experimental medication BMS-986231 in patients with different levels of kidney function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Renal Impairment | Experimental | Drug: BMS-986231Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2 |
| Moderate renal impairment | Experimental | Drug: BMS-986231Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2 |
| Severe renal impairment | Experimental | Drug: BMS-986231Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis |
| Normal renal function | Experimental | Drug: BMS-986231Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body weight ≥ 45 kg and ≤ 120 kg
- BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
- Heart rate ≥ 50 bpm and < 95 bpm
- Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
- No changes in medication within 30 days prior to study drug administration
Key exclusion criteria (6 listed)
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
- History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal
- History of migraine or cluster headaches
- Patients requiring dialysis will not be enrolled in this study
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-986231Intravenous infusion administration | Drug | Mild Renal Impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Maximum observed plasma concentration (Cmax) derived from plasma concentration
Time frame: 11 days
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
Time frame: 11 days
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
Time frame: 11 days
Clearance (CL) derived from plasma concentration
Time frame: 11 days
Renal clearance (CLR) derived from urine concentration
Time frame: 11 days
9 secondary outcomes
Number of adverse events (AE)
Time frame: Up to 31 days
Number of serious adverse events (SAE)
Time frame: Up to 31 days
Terminal elimination half-life (t1/2)
Time frame: Up to 36 hours
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 36 hours
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
Time frame: Up to 36 hours
Terminal elimination phase rate constant (λz)
Time frame: Up to 36 hours
Volume of distribution during terminal phase (Vz)
Time frame: Up to 36 hours
Fraction of administered drug excreted into urine (Fe)
Time frame: Up to 36 hours
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)
Time frame: Up to 36 hours
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 11 Sep 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986231 in people with Myocardial Failure and Cardiac Failure, run by Bristol-Myers Squibb at 3 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 5 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 11 Sep 2019. 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 Poland, Czechia. 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?
Maximum observed plasma concentration (Cmax) derived from plasma concentration (time frame: 11 days). The study lists 5 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 11 Sep 2019.