Liver DysfunctionPhase 1NCT03515980
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
A Phase 1 study testing BMS-986231 in people with Liver Dysfunction and Liver Insufficiency, run by Bristol-Myers Squibb at 4 sites in 2 countries.
Trial summary
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Dysfunction, Liver Insufficiency, Hepatic 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
- 76 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 May 2018to 29 Aug 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- Heart rate ≥ 50 bpm and < 95 bpm
- Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment
Who cannot join
- 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
- History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
- History of migraine or cluster headaches
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Hungary2 sites
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, 1083
Clinical Research Unit Hungary
Miskolc, 3529
Poland2 sites
BioVirtus Centrum Medyczne
Józefów, 05-410
KO-MED Centra Kliniczne Lublin
Lublin, 20-954
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 Participants With Varying Degrees of Hepatic Impairment
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
- Conditions
- Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure, Cardiac Failure, Congestive Heart Failure
- Being tested
- BMS-986231
- Medical subject headings
- Liver Diseases, Hepatic Insufficiency, Liver Failure, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986231Drug
Intravenous (IV) administration
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points Receives: Drug: BMS-986231 |
| Moderate hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points Receives: Drug: BMS-986231 |
| Severe hepatic impairment | Experimental | Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points Receives: Drug: BMS-986231 |
| Normal hepatic function | Experimental | Based on Hepatic Function Impairment as defined by the investigator Receives: Drug: BMS-986231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
Measured: Up to 2 days
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
Measured: Up to 2 days
Maximum plasma concentration (Cmax)
Measured: Up to 2 days
Secondary outcomes (9)
Incidence of adverse events (AE)
Measured: Up to 33 days
Incidence of serious adverse events (SAE)
Measured: Up to 33 days
Incidence of Laboratory Test Result Abnormalities
Measured: Up to 11 days
Clearance (CL) derived from plasma concentration
Measured: Up to 2 days
Terminal elimination half-life (t1/2) derived from plasma concentration
Measured: Up to 2 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 2 days
Terminal elimination phase rate constant (λz) derived from plasma concentration
Measured: Up to 2 days
Volume of distribution during terminal phase (Vz) derived from plasma concentration
Measured: Up to 2 days
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start25 May 2018
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies 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
- 76 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
- NCT03515980
- Sponsor's protocol ID
- CV013-026
- Other IDs
- 2017-004914-24, 2017
- Status last verified
- Aug 2020
- First submitted
- 24 Apr 2018
- Last updated
- 27 Aug 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 27 Aug 2020. 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 Participants With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03515980
- Acronym / sponsor ID
- CV013-026
- Conditions
- Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure, Cardiac Failure, Congestive Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 4 May 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.
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver 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 hepatic impairment | Experimental | Drug: BMS-986231Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points |
| Moderate hepatic impairment | Experimental | Drug: BMS-986231Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points |
| Severe hepatic impairment | Experimental | Drug: BMS-986231Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points |
| Normal hepatic function | Experimental | Drug: BMS-986231Based on Hepatic Function Impairment as defined by the investigator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- Heart rate ≥ 50 bpm and < 95 bpm
- Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment
Key exclusion criteria (4 listed)
- 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
- History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
- History of migraine or cluster headaches
- 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-986231Intravenous (IV) administration | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function, Severe hepatic impairment |
Primary outcome
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
Time frame: Up to 2 days
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
Time frame: Up to 2 days
Maximum plasma concentration (Cmax)
Time frame: Up to 2 days
9 secondary outcomes
Incidence of adverse events (AE)
Time frame: Up to 33 days
Incidence of serious adverse events (SAE)
Time frame: Up to 33 days
Incidence of Laboratory Test Result Abnormalities
Time frame: Up to 11 days
Clearance (CL) derived from plasma concentration
Time frame: Up to 2 days
Terminal elimination half-life (t1/2) derived from plasma concentration
Time frame: Up to 2 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 2 days
Terminal elimination phase rate constant (λz) derived from plasma concentration
Time frame: Up to 2 days
Volume of distribution during terminal phase (Vz) derived from plasma concentration
Time frame: Up to 2 days
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration
Time frame: Up to 2 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 27 Aug 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
4 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 Liver Dysfunction and Liver Insufficiency, run by Bristol-Myers Squibb at 4 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 3 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary, Poland. 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?
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration (time frame: Up to 2 days). The study lists 3 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 27 Aug 2020.