Moderate Liver ImpairmentPhase 1NCT04634149
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
A Phase 1 study testing BMS-986036 in people with Moderate Liver Impairment and Severe Liver Impairment, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Liver Impairment, Severe Liver Impairment
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Nov 2020to 2 Jun 2022
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
- Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2)
Who cannot join
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
- History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution - 0002
Miami, Florida, 33014
Local Institution
Orlando, Florida, 32809
Local Institution - 0001
San Antonio, Texas, 78215
About this study
Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
- Conditions
- Moderate Liver Impairment, Severe Liver Impairment
- Being tested
- BMS-986036
- Keywords
- Cirrhosis, Hepatic impairment, Liver impairment, Nonalcoholic steatohepatitis (NASH)
- Medical subject headings
- Fibrosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986036Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A: Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: BMS-986036 |
| Group B: Severe Hepatic Impairment | Experimental | Not described Receives: Drug: BMS-986036 |
| Group C: Normal Hepatic Function | Experimental | Not described Receives: Drug: BMS-986036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 29 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))
Measured: Up to 29 days
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to 31 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 31 days
Number of participants with vital sign abnormalities
Measured: Up to 31 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 31 days
Number of participants with physical examination abnormalities
Measured: Up to 31 days
Maximum observed plasma concentration (Cmax)
Measured: Up to 29 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start23 Nov 2020
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Liver 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT04634149
- Sponsor's protocol ID
- MB130-112
- Status last verified
- Jun 2022
- First submitted
- 12 Nov 2020
- Last updated
- 16 Jun 2022
- 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 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT04634149
- Acronym / sponsor ID
- MB130-112
- Conditions
- Moderate Liver Impairment, Severe Liver Impairment
- Keywords
- Cirrhosis, Hepatic impairment, Liver impairment, Nonalcoholic steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 18 Nov 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 purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Moderate Hepatic Impairment | Experimental | Drug: BMS-986036 |
| Group B: Severe Hepatic Impairment | Experimental | Drug: BMS-986036 |
| Group C: Normal Hepatic Function | Experimental | Drug: BMS-986036 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
- Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2)
Key exclusion criteria (3 listed)
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
- History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- 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-986036Specified dose on specified days | Drug | Group A: Moderate Hepatic Impairment, Group B: Severe Hepatic Impairment, Group C: Normal Hepatic Function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 29 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))
Time frame: Up to 29 days
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 31 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 31 days
Number of participants with vital sign abnormalities
Time frame: Up to 31 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 31 days
Number of participants with physical examination abnormalities
Time frame: Up to 31 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 29 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))
Time frame: Up to 29 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 16 Jun 2022.
- 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.
Related trials for Moderate Liver Impairment
RecruitingPhase 1
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
Healthy, Hepatic Impairment
Not yet recruitingPhase 1
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
Hepatic Insufficiency, Liver Diseases
RecruitingPhase 1
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
Healthy, Hepatic Insufficiency
RecruitingPhase 1
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Cholestatic Liver Disease
RecruitingPhase 1
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Moderate Hepatic Impairment
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-986036 in people with Moderate Liver Impairment and Severe Liver Impairment, 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 3 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 16 Jun 2022. 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) (time frame: Up to 29 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 16 Jun 2022.