Renal FailurePhase 1NCT04237831
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
A Phase 1 study testing BMS-986259 in people with Renal Failure, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- BMS-986259
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Feb 2020to 16 Jul 2021
- 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
- Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
- No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
- Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
- Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
- Women and men must use highly effective methods of contraception for the duration of treatment
Who cannot join
- History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
- Positive results for drugs abuse in urine/saliva
- Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
- Known previous exposure to BMS-986259
- Other inclusion/exclusion criteria 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 Clinical Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
Read the detailed description
Recruitment temporarily on hold due to COVID-19
- Conditions
- Renal Failure
- Being tested
- BMS-986259
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986259Drug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Normal Renal Function | Experimental | Not described Receives: Drug: BMS-986259 |
| Arm B: Mild Renal Impairment | Experimental | Not described Receives: Drug: BMS-986259 |
| Arm C: Moderate Renal Impairment | Experimental | Not described Receives: Drug: BMS-986259 |
| Arm D: Severe Renal Impairment | Experimental | Not described Receives: Drug: BMS-986259 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Measured: Day 1 and Day 8
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Measured: Day 1 and Day 8
Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
Measured: Day 1 and Day 8
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Measured: Day 1 and Day 8
Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)
Measured: Day 8
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Measured: Day 8
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Measured: Day 8
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Measured: Day 8
Terminal elimination half-life of BMS-986259 (T-HALF)
Measured: Day 8
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Measured: Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
Measured: Day 8
Secondary outcomes (7)
Incidence of Non serious Adverse Events (AEs)
Measured: Up to 4 months
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 4 months
Incidence of AEs leading to discontinuation
Measured: Up to 4 months
Number of clinically significant changes in vital signs
Measured: Up to 4 months
Number in clinically significant changes in Electrocardiogram (ECG)
Measured: Up to 4 months
Number of clinically significant changes in physical examinations
Measured: Up to 4 months
Number of clinically significant changes in clinical laboratory tests
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start26 Feb 2020
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04237831
- Sponsor's protocol ID
- CV019-008
- Status last verified
- Sep 2021
- First submitted
- 19 Jan 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT04237831
- Acronym / sponsor ID
- CV019-008
- Conditions
- Renal Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 23 Jan 2020 (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.
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
Detailed description
Recruitment temporarily on hold due to COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Normal Renal Function | Experimental | Drug: BMS-986259 |
| Arm B: Mild Renal Impairment | Experimental | Drug: BMS-986259 |
| Arm C: Moderate Renal Impairment | Experimental | Drug: BMS-986259 |
| Arm D: Severe Renal Impairment | Experimental | Drug: BMS-986259 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
- No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
- Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
- Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
- Women and men must use highly effective methods of contraception for the duration of treatment
Key exclusion criteria (6 listed)
- History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
- Positive results for drugs abuse in urine/saliva
- Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
- Known previous exposure to BMS-986259
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-986259Specified Dose on Specified Days | Drug | Arm A: Normal Renal Function, Arm B: Mild Renal Impairment, Arm C: Moderate Renal Impairment, Arm D: Severe Renal Impairment |
Primary outcome
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Time frame: Day 1 and Day 8
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Time frame: Day 1 and Day 8
Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
Time frame: Day 1 and Day 8
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Time frame: Day 1 and Day 8
Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)
Time frame: Day 8
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Time frame: Day 8
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Time frame: Day 8
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Time frame: Day 8
Terminal elimination half-life of BMS-986259 (T-HALF)
Time frame: Day 8
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Time frame: Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
Time frame: Day 8
7 secondary outcomes
Incidence of Non serious Adverse Events (AEs)
Time frame: Up to 4 months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 months
Incidence of AEs leading to discontinuation
Time frame: Up to 4 months
Number of clinically significant changes in vital signs
Time frame: Up to 4 months
Number in clinically significant changes in Electrocardiogram (ECG)
Time frame: Up to 4 months
Number of clinically significant changes in physical examinations
Time frame: Up to 4 months
Number of clinically significant changes in clinical laboratory tests
Time frame: Up to 4 months
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 24 Sep 2021.
- 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-986259 in people with Renal 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 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 24 Sep 2021. 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 plasma Concentration (Cmax) of BMS-986259 in Blood serum (time frame: Day 1 and Day 8). The study lists 11 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 24 Sep 2021.