Hepatic CirrhosisPhase 1NCT03445208
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
A Phase 1 study testing BMS-986036 in people with Hepatic Cirrhosis and Liver Fibrosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is a study of experimental medication BMS-986036 given to healthy participants. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 2 May 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- BMI of 18 to ≤ 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 (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Known or suspected autoimmune disorder, excluding vitiligo
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
Show all 9Show fewer
- Any major surgery within 6 weeks of study drug administration
- History of diabetes mellitus
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants
This is a study of experimental medication BMS-986036 given to healthy participants.
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Being tested
- BMS-986036
- Medical subject headings
- Liver Cirrhosis, 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
Crossover administration to abdomen then upper arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BMI 18.0 to ≤ 25.0 Receives: Drug: BMS-986036 |
| Cohort 2 | Experimental | BMI >25.0 to ≤ 30.0 Receives: Drug: BMS-986036 |
| Cohort 3 | Experimental | BMI >30.0 ≤ 40.0 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)
Measured: 29 days
Time of maximum observed serum concentration (Tmax)
Measured: 29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
Measured: 29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
Measured: 29 days
Secondary outcomes (6)
Number of injection site reactions
Measured: Up to 78 days
Number of adverse events (AE)
Measured: Up to 78 days
Number of serious adverse events (SAE)
Measured: Up to 78 days
Number of AEs leading to discontinuation
Measured: Up to 78 days
Number of deaths
Measured: Up to 78 days
Serum biomarker antibody concentration
Measured: Up to 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start14 Feb 2018
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CirrhosisStudies 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
- Crossover
- 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
- NCT03445208
- Sponsor's protocol ID
- MB130-070
- Status last verified
- Mar 2020
- First submitted
- 20 Feb 2018
- Last updated
- 19 Mar 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants
- ClinicalTrials.gov ID
- NCT03445208
- Acronym / sponsor ID
- MB130-070
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 26 Feb 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 a study of experimental medication BMS-986036 given to healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BMS-986036BMI 18.0 to ≤ 25.0 |
| Cohort 2 | Experimental | Drug: BMS-986036BMI >25.0 to ≤ 30.0 |
| Cohort 3 | Experimental | Drug: BMS-986036BMI >30.0 ≤ 40.0 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- BMI of 18 to ≤ 40 kg/m2
Key exclusion criteria (9 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 (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Known or suspected autoimmune disorder, excluding vitiligo
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- Any significant acute or chronic medical illness
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-986036Crossover administration to abdomen then upper arm | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum observed serum concentration (Cmax)
Time frame: 29 days
Time of maximum observed serum concentration (Tmax)
Time frame: 29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
Time frame: 29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
Time frame: 29 days
6 secondary outcomes
Number of injection site reactions
Time frame: Up to 78 days
Number of adverse events (AE)
Time frame: Up to 78 days
Number of serious adverse events (SAE)
Time frame: Up to 78 days
Number of AEs leading to discontinuation
Time frame: Up to 78 days
Number of deaths
Time frame: Up to 78 days
Serum biomarker antibody concentration
Time frame: Up to 78 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 19 Mar 2020.
- BMS Clinical Trial InformationLink 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-986036 in people with Hepatic Cirrhosis and Liver Fibrosis, 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 2 inclusion and 9 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 19 Mar 2020. 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) (time frame: 29 days). The study lists 4 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 19 Mar 2020.