Cardiac FailurePhase 1NCT03634969
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
A Phase 1 study testing BMS-986224 in people with Cardiac Failure and Myocardial Failure, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Failure, Myocardial Failure
- What is being tested?
- BMS-986224
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Aug 2018to 30 Apr 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥18 and ≤ 35kg/m2
- Systolic blood pressure >100 mmHg
Who cannot join
- Women of childbearing potential or women who are currently pregnant
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.
- Conditions
- Cardiac Failure, Myocardial Failure
- Being tested
- BMS-986224
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986224Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function | Experimental | Not described Receives: Drug: BMS-986224 |
| Mild Renal Impairment | Experimental | Not described Receives: Drug: BMS-986224 |
| Moderate Renal Impairment | Experimental | Not described Receives: Drug: BMS-986224 |
| Severe Renal Impairment | Experimental | Not described Receives: Drug: BMS-986224 |
| End-Stage Renal Disease (ESRD) | Experimental | ESRD participants and are on chronic hemodialysis Receives: Drug: BMS-986224 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986224
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Measured: Up to 11 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Measured: Up to 11 days
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
Measured: Up to 11 days
Fraction of unbound drug in plasma (fu) of BMS-986224
Measured: Up to 11 days
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
Measured: Up to 11 days
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
Measured: Up to 11 days
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
Part 1 only
Measured: 7 days
Fraction of dose excreted in urine (Fe%) of BMS-986224
Part 1 only
Measured: 7 days
Renal clearance of BMS-986224 derived from urine concentration
Part 1 only
Measured: 7 days
Secondary outcomes (12)
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Measured: Up to 41 days
Maximum observed plasma concentration (Cmax) of metabolite
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
Measured: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
Measured: Up to 11 days
Time of maximum observed plasma concentration (Tmax) of metabolite
Measured: Up to 11 days
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
Measured: Up to 11 days
Metabolite-to-parent (MR) ratio for cMax
Measured: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-T)
Measured: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-72)
Measured: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(INF)
Measured: Up to 11 days
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
Measured: Up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start14 Aug 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- 50 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
- NCT03634969
- Sponsor's protocol ID
- CV016-010
- Status last verified
- Feb 2020
- First submitted
- 15 Aug 2018
- Last updated
- 25 Feb 2020
- 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT03634969
- Acronym / sponsor ID
- CV016-010
- Conditions
- Cardiac Failure, Myocardial Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Aug 2018 (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 the experimental medication BMS-986224 in participants with varying levels of renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function | Experimental | Drug: BMS-986224 |
| Mild Renal Impairment | Experimental | Drug: BMS-986224 |
| Moderate Renal Impairment | Experimental | Drug: BMS-986224 |
| Severe Renal Impairment | Experimental | Drug: BMS-986224 |
| End-Stage Renal Disease (ESRD) | Experimental | Drug: BMS-986224ESRD participants and are on chronic hemodialysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥18 and ≤ 35kg/m2
- Systolic blood pressure >100 mmHg
Key exclusion criteria (4 listed)
- Women of childbearing potential or women who are currently pregnant
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- Other protocol defined inclusion/exclusion criteria could apply
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-986224Specified dose on specified days | Drug | End-Stage Renal Disease (ESRD), Mild Renal Impairment, Moderate Renal Impairment, Normal Renal Function, Severe Renal Impairment |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986224
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time frame: Up to 11 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Time frame: Up to 11 days
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
Fraction of unbound drug in plasma (fu) of BMS-986224
Time frame: Up to 11 days
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
Time frame: Up to 11 days
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
Time frame: 7 days
Part 1 only
Fraction of dose excreted in urine (Fe%) of BMS-986224
Time frame: 7 days
Part 1 only
Renal clearance of BMS-986224 derived from urine concentration
Time frame: 7 days
Part 1 only
12 secondary outcomes
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: Up to 41 days
Maximum observed plasma concentration (Cmax) of metabolite
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
Time frame: Up to 11 days
Time of maximum observed plasma concentration (Tmax) of metabolite
Time frame: Up to 11 days
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
Time frame: Up to 11 days
Metabolite-to-parent (MR) ratio for cMax
Time frame: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-T)
Time frame: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-72)
Time frame: Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(INF)
Time frame: Up to 11 days
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
Time frame: Up to 11 days
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 25 Feb 2020.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986224 in people with Cardiac Failure and Myocardial Failure, run by Bristol-Myers Squibb at 3 sites 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 2 inclusion and 4 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 25 Feb 2020. 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 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?
Maximum observed plasma concentration (Cmax) of BMS-986224 (time frame: Up to 11 days). The study lists 12 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 25 Feb 2020.