Healthy ParticipantsPhase 1NCT04493567
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
A Phase 1 study testing BMS-986036 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2020to 11 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to ≤ 40 kg/m2
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Who cannot join
- Women who are pregnant or breastfeeding
- Inability to tolerate subcutaneous (SC) injections
- Inability to be venipunctured and/or tolerate venous access
- Any sound medical, psychiatric, and/or social reason as determined by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials
Anaheim, California, 92801
ICON (LPRA) - Salt Lake
Salt Lake City, Utah, 84124
About this study
Official title: An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986036
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 |
|---|---|---|
| Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe | Experimental | Not described Receives: Drug: BMS-986036 |
| Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe | 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 serum concentration (Cmax)
Measured: Up to 29 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to 29 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 29 days
Secondary outcomes (16)
Incidence of adverse events (AEs)
Measured: Up to 115 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 85 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 85 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 85 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 85 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
The PR interval is the time from the onset of the P wave to the start of the QRS complex.
Measured: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Measured: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
Measured: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Corrected QT interval using Fridericia's formula (QTcF)
Measured: Up to 85 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 85 days
Number of participants with local injection site reactions
Measured: Up to 57 days
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
Measured: Up to 57 days
Number of participants with Antibodies to BMS-986036
Measured: Up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start29 Jul 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT04493567
- Sponsor's protocol ID
- MB130-101
- Status last verified
- Mar 2022
- First submitted
- 28 Jul 2020
- Last updated
- 18 Mar 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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
- ClinicalTrials.gov ID
- NCT04493567
- Acronym / sponsor ID
- MB130-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 30 Jul 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 develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe | Experimental | Drug: BMS-986036 |
| Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe | Experimental | Drug: BMS-986036 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to ≤ 40 kg/m2
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Key exclusion criteria (5 listed)
- Women who are pregnant or breastfeeding
- Inability to tolerate subcutaneous (SC) injections
- Inability to be venipunctured and/or tolerate venous access
- Any sound medical, psychiatric, and/or social reason as determined by the investigator
- 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 | Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe, Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe |
Primary outcome
Maximum observed serum concentration (Cmax)
Time frame: Up to 29 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to 29 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 29 days
16 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 115 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Time frame: Up to 85 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 85 days
Number of participants with local injection site reactions
Time frame: Up to 57 days
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
Time frame: Up to 57 days
Number of participants with Antibodies to BMS-986036
Time frame: Up to 57 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 18 Mar 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.
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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
2 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 Healthy Participants, run by Bristol-Myers Squibb at 2 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 3 inclusion and 5 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 serum 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 18 Mar 2022.