Healthy VolunteersPhase 1NCT06715683
A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants
A Phase 1 study testing BMS-986278 Batched method, Dose A, BMS-986278 Batched method, Dose B and BMS-986278 Continuous method in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986278 Batched method, Dose A, BMS-986278 Batched method, Dose B and BMS-986278 Continuous method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 16 Mar 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator.
- Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Who cannot join
- Any significant acute or chronic medical illness as determined by the investigator.
- Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable).
- Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention [uncomplicated appendectomy and hernia repair are acceptable]).
- History of known risk of bleeding.
- Inability to tolerate oral medication.
- Individuals (only females) who are of childbearing potential.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials (ACT)
Anaheim, California, 92801
About this study
Official title: An Open-label, Randomized, 2-Part, 4-Period, 2-Sequence, Fully Replicated Crossover Study to Assess the Comparative Bioavailability of BMS-986278 To-be-marketed Formulation Compared to the Phase 3 Clinical Trial Formulation in Healthy Participants
This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986278 Batched method, Dose A, BMS-986278 Batched method, Dose B, BMS-986278 Continuous method
- Keywords
- Pharmacokinetics, Comparative Bioavailability, BMS-986278
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278 Batched method, Dose ADrug
Specified dose on specified days
BMS-986278 Batched method, Dose BDrug
Specified dose on specified days
BMS-986278 Continuous methodDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Sequence 1 | Experimental | Not described Receives: Drug: BMS-986278 Batched method, Dose A; Drug: BMS-986278 Batched method, Dose B |
| Part 1, Sequence 2 | Experimental | Not described Receives: Drug: BMS-986278 Batched method, Dose A; Drug: BMS-986278 Batched method, Dose B |
| Part 2, Sequence 1 | Experimental | Not described Receives: Drug: BMS-986278 Batched method, Dose A; Drug: BMS-986278 Continuous method |
| Part 2, Sequence 2 | Experimental | Not described Receives: Drug: BMS-986278 Batched method, Dose A; Drug: BMS-986278 Continuous method |
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 Day 24
Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))
Measured: Up to Day 24
Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))
Measured: Up to Day 24
Secondary outcomes (8)
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Up to Day 24
Terminal Phase Half-life (T-HALF)
Measured: Up to Day 24
Apparent Total Body Clearance (CLT/F)
Measured: Up to Day 24
Apparent Volume of Distribution (Vz/F)
Measured: Up to Day 24
Number of Participants With Adverse Events (AEs)
Measured: Up to 28 Days Post-discontinuation of Study Intervention
Number of Participants With Clinical Laboratory Abnormalities
Measured: Up to Day 25
Number of Participants With Vital Sign Abnormalities
Measured: Up to Day 25
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Measured: Up to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start12 Dec 2024
- Primary completion16 Mar 2025
- Study completion16 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 48 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
- NCT06715683
- Sponsor's protocol ID
- IM027-1035
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-Part, 4-Period, 2-Sequence, Fully Replicated Crossover Study to Assess the Comparative Bioavailability of BMS-986278 To-be-marketed Formulation Compared to the Phase 3 Clinical Trial Formulation in Healthy Participants
- ClinicalTrials.gov ID
- NCT06715683
- Acronym / sponsor ID
- IM027-1035
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Comparative Bioavailability, BMS-986278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 4 Dec 2024 (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 trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1, Sequence 1 | Experimental | Drug: BMS-986278 Batched method, Dose A, Drug: BMS-986278 Batched method, Dose B |
| Part 1, Sequence 2 | Experimental | Drug: BMS-986278 Batched method, Dose A, Drug: BMS-986278 Batched method, Dose B |
| Part 2, Sequence 1 | Experimental | Drug: BMS-986278 Batched method, Dose A, Drug: BMS-986278 Continuous method |
| Part 2, Sequence 2 | Experimental | Drug: BMS-986278 Batched method, Dose A, Drug: BMS-986278 Continuous method |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator.
- Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Key exclusion criteria (7 listed)
- Any significant acute or chronic medical illness as determined by the investigator.
- Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable).
- Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention [uncomplicated appendectomy and hernia repair are acceptable]).
- History of known risk of bleeding.
- Inability to tolerate oral medication.
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-986278 Batched method, Dose ASpecified dose on specified days | Drug | Part 1, Sequence 1, Part 1, Sequence 2, Part 2, Sequence 1, Part 2, Sequence 2 |
| BMS-986278 Batched method, Dose BSpecified dose on specified days | Drug | Part 1, Sequence 1, Part 1, Sequence 2 |
| BMS-986278 Continuous methodSpecified dose on specified days | Drug | Part 2, Sequence 1, Part 2, Sequence 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 24
Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))
Time frame: Up to Day 24
Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))
Time frame: Up to Day 24
8 secondary outcomes
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 24
Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 24
Apparent Total Body Clearance (CLT/F)
Time frame: Up to Day 24
Apparent Volume of Distribution (Vz/F)
Time frame: Up to Day 24
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 Days Post-discontinuation of Study Intervention
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to Day 25
Number of Participants With Vital Sign Abnormalities
Time frame: Up to Day 25
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 25
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 4 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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-986278 Batched method, Dose A, BMS-986278 Batched method, Dose B and BMS-986278 Continuous method in people with Healthy Volunteers, 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 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 4 Apr 2025. 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 Plasma Concentration (Cmax) (time frame: Up to Day 24). 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 4 Apr 2025.