NAFLDPhase 1NCT03674476
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
A Phase 1 study testing BMS-986036 in people with NAFLD and Nonalcoholic Fatty Liver Disease, run by Bristol-Myers Squibb at 4 sites in 2 countries.
Trial summary
This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Sep 2018to 24 Jun 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 25 and ≤ 40 kg/m2
Who cannot join
- Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
- Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
- Inability to tolerate subcutaneous injections
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Hungary3 sites
PRA Magyarorszag Kft
Budapest, 1077
Semmelweis Egyetem
Budapest, 1083
Clinical Research Unit Hungary
Miskolc, 3529
About this study
Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Varying Degrees of Renal Function
This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.
- Being tested
- BMS-986036
- Medical subject headings
- 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 |
|---|---|---|
| Mild Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. Receives: Drug: BMS-986036 |
| Moderate Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. Receives: Drug: BMS-986036 |
| Severe Renal Impairment | Experimental | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. Receives: Drug: BMS-986036 |
| Normal | Other | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. Receives: Drug: BMS-986036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
Measured: Up to 30 days
Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
Measured: Up to 30 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036
Measured: Up to 30 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Measured: Up to 30 days
Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
Measured: Up to 30 days
Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
Measured: Up to 30 days
Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
Measured: Up to 30 days
Total renal clearance (CLR) of C-terminal intact BMS-986036
Measured: Up to 30 days
Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
Measured: Up to 30 days
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036
Measured: Up to 30 days
Secondary outcomes (14)
Maximum observed serum concentration (Cmax) of total BMS-986036
Measured: Up to 30 days
Time of maximum observed serum concentration (Tmax) of total BMS-986036
Measured: Up to 30 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036
Measured: Up to 30 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036
Measured: Up to 30 days
Terminal elimination half-life (T-half) of total BMS-986036
Measured: Up to 30 days
Apparent total body clearance (CLT/F) of total BMS-986036
Measured: Up to 30 days
Apparent volume of distribution (Vz/F) of total BMS-986036
Measured: Up to 30 days
Total renal clearance (CLR) of total BMS-986036
Measured: Up to 30 days
Amount per fraction excreted into urine (Fe) of total BMS-986036
Measured: Up to 30 days
Total amount excreted into urine (Ae) of total BMS-986036
Measured: Up to 30 days
Incidence of injection site reactions (prospective)
Measured: Up to 30 days
Incidence of adverse events (AE)
Measured: Up to 30 days
Incidence of serious adverse events (SAE)
Measured: Up to 30 days
Incidence of clinically significant changes to events of special interest
Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start11 Sep 2018
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- 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
- NCT03674476
- Sponsor's protocol ID
- MB130-065
- Other IDs
- 2018-001497-19, 2018
- Status last verified
- Oct 2019
- First submitted
- 29 Aug 2018
- Last updated
- 8 Oct 2019
- 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 8 Oct 2019. 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-986036 in Participants With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT03674476
- Acronym / sponsor ID
- MB130-065
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 17 Sep 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 to evaluate the experimental medication BMS-986036 in participants with different levels of kidney 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 Renal Impairment | Experimental | Drug: BMS-986036The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Moderate Renal Impairment | Experimental | Drug: BMS-986036The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Severe Renal Impairment | Experimental | Drug: BMS-986036The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Normal | Other | Drug: BMS-986036The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 25 and ≤ 40 kg/m2
Key exclusion criteria (7 listed)
- Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
- Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
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 | Mild Renal Impairment, Moderate Renal Impairment, Normal, Severe Renal Impairment |
Primary outcome
Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036
Time frame: Up to 30 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Time frame: Up to 30 days
Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Total renal clearance (CLR) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
Time frame: Up to 30 days
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036
Time frame: Up to 30 days
14 secondary outcomes
Maximum observed serum concentration (Cmax) of total BMS-986036
Time frame: Up to 30 days
Time of maximum observed serum concentration (Tmax) of total BMS-986036
Time frame: Up to 30 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036
Time frame: Up to 30 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036
Time frame: Up to 30 days
Terminal elimination half-life (T-half) of total BMS-986036
Time frame: Up to 30 days
Apparent total body clearance (CLT/F) of total BMS-986036
Time frame: Up to 30 days
Apparent volume of distribution (Vz/F) of total BMS-986036
Time frame: Up to 30 days
Total renal clearance (CLR) of total BMS-986036
Time frame: Up to 30 days
Amount per fraction excreted into urine (Fe) of total BMS-986036
Time frame: Up to 30 days
Total amount excreted into urine (Ae) of total BMS-986036
Time frame: Up to 30 days
Incidence of injection site reactions (prospective)
Time frame: Up to 30 days
Incidence of adverse events (AE)
Time frame: Up to 30 days
Incidence of serious adverse events (SAE)
Time frame: Up to 30 days
Incidence of clinically significant changes to events of special interest
Time frame: Up to 30 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 8 Oct 2019.
- 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-986036 in people with NAFLD and Nonalcoholic Fatty Liver Disease, 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 1 inclusion and 7 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 8 Oct 2019. 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, Czechia. 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 C-terminal intact BMS-986036 (time frame: Up to 30 days). The study lists 10 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 8 Oct 2019.