Healthy ParticipantsPhase 1NCT04468815

A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

A Phase 1 study testing BMS-986278 Tablet, Esomeprazole and BMS-986278 suspension in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: BMS-986278 Tablet, Esomeprazole and BMS-986278 suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 10 Jul 2020to 7 Oct 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
Women and men must agree to follow specific methods of contraception

Who cannot join

Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding
Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON (LPRA) - Salt Lake
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Conditions: Healthy Participants
Being tested: BMS-986278 Tablet, Esomeprazole, BMS-986278 suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986278 TabletDrug
Specified dose on specified days
EsomeprazoleDrug
Also called NEXIUM
Specified dose on specified days
BMS-986278 suspensionDrug
Specified dose on specified days

Study groups in NCT04468815
Study group	Role	What they receive
Treatment A: BMS-986278 suspension, fasted	Experimental	Not described Receives: Drug: BMS-986278 suspension
Treatment B: BMS-986278 tablet, fasted	Experimental	Not described Receives: Drug: BMS-986278 Tablet
Treatment C: BMS-986278 tablet, fed	Experimental	Not described Receives: Drug: BMS-986278 Tablet
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted	Experimental	Not described Receives: Drug: BMS-986278 Tablet; Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum plasma concentration (Cmax) of BMS-986278
Measured: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
Measured: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
Measured: Up to 5 days

Secondary outcomes (12)

Incidence of Adverse Events (AEs)
Measured: Up to 29 days
Incidence of Serious Adverse (SAE's)
Measured: Up to 57 days
Incidence of AEs leading to discontinuation
Measured: Up to 29 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 48 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 48 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 48 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 48 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 48 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Measured: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 48 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20207 Oct 2020

First posted13 Jul 2020
Study start10 Jul 2020
Primary completion7 Oct 2020
Study completion7 Oct 2020

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04468815
Sponsor's protocol ID: IM027-054
Status last verified: May 2022
First submitted: 9 Jul 2020
Last updated: 10 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants
ClinicalTrials.gov ID: NCT04468815
Acronym / sponsor ID: IM027-054
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 10 Jul 2020 (actual)
Primary completion: 7 Oct 2020 (actual)
Study completion: 7 Oct 2020 (actual)
First posted: 13 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 assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A: BMS-986278 suspension, fasted	Experimental	Drug: BMS-986278 suspension
Treatment B: BMS-986278 tablet, fasted	Experimental	Drug: BMS-986278 Tablet
Treatment C: BMS-986278 tablet, fed	Experimental	Drug: BMS-986278 Tablet
Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted	Experimental	Drug: BMS-986278 Tablet, Drug: Esomeprazole

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
Women and men must agree to follow specific methods of contraception

Key exclusion criteria (5 listed)

Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding
Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)
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-986278 TabletSpecified dose on specified days	Drug	Treatment B: BMS-986278 tablet, fasted, Treatment C: BMS-986278 tablet, fed, Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
EsomeprazoleAlso: NEXIUMSpecified dose on specified days	Drug	Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted
BMS-986278 suspensionSpecified dose on specified days	Drug	Treatment A: BMS-986278 suspension, fasted

Primary outcome

Maximum plasma concentration (Cmax) of BMS-986278
Time frame: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
Time frame: Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
Time frame: Up to 5 days

12 secondary outcomes

Incidence of Adverse Events (AEs)
Time frame: Up to 29 days
Incidence of Serious Adverse (SAE's)
Time frame: Up to 57 days
Incidence of AEs leading to discontinuation
Time frame: Up to 29 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 48 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 48 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 48 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 48 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 48 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Time frame: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 48 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 48 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 10 May 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

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 Tablet, Esomeprazole and BMS-986278 suspension 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 2 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 10 May 2022. 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 plasma concentration (Cmax) of BMS-986278 (time frame: Up to 5 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?

On the ClinicalTrials.gov record for NCT04468815.

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 10 May 2022.