Healthy ParticipantsPhase 1NCT06568458
A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants
A Phase 1 study testing Nintedanib and BMS 986278 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet 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 Participants
- What is being tested?
- Nintedanib and BMS 986278
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to 27 Feb 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
- Participants must be healthy males and females (INOCBP)
- Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
- Participant must have Body weight ≥ 50 kg
Who cannot join
- Participant must not have current or recent GI disease
- Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
- Conditions
- Healthy Participants
- Being tested
- Nintedanib, BMS 986278
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Specified Dose on specified days
BMS 986278Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part I: Period A | Experimental | Not described Receives: Drug: Nintedanib |
| Part I: Period B | Experimental | Not described Receives: Drug: BMS 986278 |
| Part I: Period C | Experimental | Not described Receives: Drug: Nintedanib; Drug: BMS 986278 |
| Part II: Period 1 | Experimental | Not described Receives: Drug: BMS 986278 |
| Part II: Period 2 | Experimental | Not described Receives: Drug: BMS 986278 |
| Part II: Period 3 | Experimental | Not described Receives: Drug: BMS 986278 |
| Part III: Period 1 | Experimental | Not described Receives: Drug: BMS 986278 |
| Part III: Period 2 | Experimental | Not described Receives: Drug: BMS 986278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Measured: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
Measured: Day 4, 17 and 21 of Part 1
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Measured: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Measured: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Secondary outcomes (11)
Number of participants with non-serious AEs (Adverse events)
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with Serious AEs
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with AEs leading to discontinuation
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with Physical examination abnormalities
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with vital sign abnormalities
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to 28 Days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Measured: Up to 28 Days post discontinuation of dosing
Time of maximum observed plasma concentration (Tmax)
Measured: Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)
Apparent terminal phase half-life (T-HALF)
Measured: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent total body clearance (CLT/F)
Measured: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start19 Sep 2024
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 71 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
- NCT06568458
- Sponsor's protocol ID
- IM027-1026
- Status last verified
- Mar 2025
- First submitted
- 21 Aug 2024
- Last updated
- 14 Mar 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/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants
- ClinicalTrials.gov ID
- NCT06568458
- Acronym / sponsor ID
- IM027-1026
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 23 Aug 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.
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part I: Period A | Experimental | Drug: Nintedanib |
| Part I: Period B | Experimental | Drug: BMS 986278 |
| Part I: Period C | Experimental | Drug: Nintedanib, Drug: BMS 986278 |
| Part II: Period 1 | Experimental | Drug: BMS 986278 |
| Part II: Period 2 | Experimental | Drug: BMS 986278 |
| Part II: Period 3 | Experimental | Drug: BMS 986278 |
| Part III: Period 1 | Experimental | Drug: BMS 986278 |
| Part III: Period 2 | Experimental | Drug: BMS 986278 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be healthy males and females (INOCBP)
- Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
- Participant must have Body weight ≥ 50 kg
Key exclusion criteria (4 listed)
- Participant must not have current or recent GI disease
- Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
- 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 |
|---|---|---|
| NintedanibSpecified Dose on specified days | Drug | Part I: Period A, Part I: Period C |
| BMS 986278Specified dose on specified days | Drug | Part I: Period B, Part I: Period C, Part II: Period 1, Part II: Period 2, Part II: Period 3, Part III: Period 1, Part III: Period 2 |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
Time frame: Day 4, 17 and 21 of Part 1
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
11 secondary outcomes
Number of participants with non-serious AEs (Adverse events)
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with Serious AEs
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with AEs leading to discontinuation
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with Physical examination abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with vital sign abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Time of maximum observed plasma concentration (Tmax)
Time frame: Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)
Apparent terminal phase half-life (T-HALF)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent total body clearance (CLT/F)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
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 14 Mar 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/disclosure-commitment.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 Nintedanib and BMS 986278 in people with Healthy Participants, 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 4 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 14 Mar 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 Serum Concentration (Cmax) (time frame: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)). 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 14 Mar 2025.