Hepatic ImpairmentPhase 1NCT04225936
A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
A Phase 1 study testing BMS-986263 in people with Hepatic Impairment, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- BMS-986263
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 1 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]).
- Participants with normal hepatic function as judged by the investigator
- Participants with hepatic impairment as judged by the investigator
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 participant.
- Any major surgery within 4 weeks of study drug administration
- Previous exposure to BMS-986263
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
- Conditions
- Hepatic Impairment
- Being tested
- BMS-986263
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986263Drug
Single Dose
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mild Hepatic Impairment | Experimental | Part 1 Receives: Drug: BMS-986263 |
| Group B: Moderate Hepatic Impairment | Experimental | Part 1 Receives: Drug: BMS-986263 |
| Group C: Severe Hepatic Impairment | Experimental | Part 2 Receives: Drug: BMS-986263 |
| Group D: Normal Hepatic function (control group) | Experimental | Part 1 Receives: Drug: BMS-986263 |
| Group E: Normal Hepatic Function (optional, control group) | Experimental | Part 2 Receives: Drug: BMS-986263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Total body clearance (CL) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Volume of distribution (Vz) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
Measured: Day 1 to Day 31
Secondary outcomes (7)
Incidence of Adverse Events (AEs)
Measured: Up to 31 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 59 days or up to 30 days after dosing (whichever is longer)
Incidence of AEs leading to discontinuation
Measured: Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).
Number of participants with abnormalities in clinical laboratory assessments
Measured: Up to 59 days
Number of participants with vital sign abnormalities
Measured: Up to 59 days
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to 59 days
Number of participants with physical examination abnormalities
Measured: Up to 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start16 Jan 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- 40 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
- NCT04225936
- Sponsor's protocol ID
- IM025-015
- Status last verified
- Oct 2021
- First submitted
- 9 Jan 2020
- Last updated
- 5 Nov 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT04225936
- Acronym / sponsor ID
- IM025-015
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 13 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.
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Mild Hepatic Impairment | Experimental | Drug: BMS-986263Part 1 |
| Group B: Moderate Hepatic Impairment | Experimental | Drug: BMS-986263Part 1 |
| Group C: Severe Hepatic Impairment | Experimental | Drug: BMS-986263Part 2 |
| Group D: Normal Hepatic function (control group) | Experimental | Drug: BMS-986263Part 1 |
| Group E: Normal Hepatic Function (optional, control group) | Experimental | Drug: BMS-986263Part 2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]).
- Participants with normal hepatic function as judged by the investigator
- Participants with hepatic impairment as judged by the investigator
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 participant.
- Any major surgery within 4 weeks of study drug administration
- Previous exposure to BMS-986263
- Other protocol-defined inclusion/exclusion criteria 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-986263Single Dose | Drug | Group A: Mild Hepatic Impairment, Group B: Moderate Hepatic Impairment, Group C: Severe Hepatic Impairment, Group D: Normal Hepatic function (control group), Group E: Normal Hepatic Function (optional, control group) |
Primary outcome
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
Total body clearance (CL) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
Volume of distribution (Vz) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
Time frame: Day 1 to Day 31
7 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 31 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 59 days or up to 30 days after dosing (whichever is longer)
Incidence of AEs leading to discontinuation
Time frame: Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).
Number of participants with abnormalities in clinical laboratory assessments
Time frame: Up to 59 days
Number of participants with vital sign abnormalities
Time frame: Up to 59 days
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to 59 days
Number of participants with physical examination abnormalities
Time frame: Up to 59 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 5 Nov 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink 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
1 site 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-986263 in people with Hepatic Impairment, run by Bristol-Myers Squibb at 1 site 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 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 serum concentration (Cmax) of components of BMS-986263 for injection (time frame: Day 1 to Day 31). The study lists 6 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 5 Nov 2021.