Healthy ParticipantsPhase 1NCT06851871
A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults
A Phase 1 study testing Deucravacitinib and Famotidine in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults. 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?
- Deucravacitinib and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 4 Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.
- Participants must be willing and able to complete all study-specific procedures and visits.
- Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).
Who cannot join
- Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator.
- Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.
- Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-dose Study in Healthy Adult Participants to Assess the Bioequivalence Between Immediate Release Tablets and Minitablets, and to Assess the Food and pH Effect on the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Minitablets
The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
- Conditions
- Healthy Participants
- Being tested
- Deucravacitinib, Famotidine
- Keywords
- Bioequivalence, Food Effect, pH Effect, Healthy Volunteers, Deucravacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Specified dose on specified days
FamotidineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165 Formulation 1 | Experimental | Not described Receives: Drug: Deucravacitinib |
| BMS-986165 Formulation 2 | Experimental | Not described Receives: Drug: Deucravacitinib |
| BMS-986165 Formulation 2 + Fed | Experimental | Not described Receives: Drug: Deucravacitinib |
| BMS-986165 Formulation 2 + Famotidine | Experimental | Not described Receives: Drug: Deucravacitinib; Drug: Famotidine |
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 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to day 20
Secondary outcomes (9)
Incidence of adverse events (AEs)
Measured: Up to day 44
Incidence of serious adverse events (SAEs)
Measured: Up to day 44
Incidence of AEs leading to discontinuation
Measured: Up to day 44
Number of participants with a clinically significant change from baseline in vital signs
Measured: Up to day 21
Number of participants with a change from baseline in 12-lead ECG results
Measured: Up to day 21
Number of participants with physical examination abnormalities
A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination
Measured: Up to day 21
Time of maximum observed plasma concentration (Tmax)
Measured: Up to day 20
Apparent terminal plasma half-life (T-HALF)
Measured: Up to day 20
Apparent total body clearance (CLT/F)
Measured: Up to day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start23 Jan 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT06851871
- Sponsor's protocol ID
- IM011-1178
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2025
- Last updated
- 29 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/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose Study in Healthy Adult Participants to Assess the Bioequivalence Between Immediate Release Tablets and Minitablets, and to Assess the Food and pH Effect on the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Minitablets
- ClinicalTrials.gov ID
- NCT06851871
- Acronym / sponsor ID
- IM011-1178
- Conditions
- Healthy Participants
- Keywords
- Bioequivalence, Food Effect, pH Effect, Healthy Volunteers, Deucravacitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 28 Feb 2025 (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 evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-986165 Formulation 1 | Experimental | Drug: Deucravacitinib |
| BMS-986165 Formulation 2 | Experimental | Drug: Deucravacitinib |
| BMS-986165 Formulation 2 + Fed | Experimental | Drug: Deucravacitinib |
| BMS-986165 Formulation 2 + Famotidine | Experimental | Drug: Deucravacitinib, Drug: Famotidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.
- Participants must be willing and able to complete all study-specific procedures and visits.
- Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).
Key exclusion criteria (4 listed)
- Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator.
- Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.
- Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs.
- 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 |
|---|---|---|
| DeucravacitinibSpecified dose on specified days | Drug | BMS-986165 Formulation 1, BMS-986165 Formulation 2, BMS-986165 Formulation 2 + Famotidine, BMS-986165 Formulation 2 + Fed |
| FamotidineSpecified dose on specified days | Drug | BMS-986165 Formulation 2 + Famotidine |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 20
9 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to day 44
Incidence of serious adverse events (SAEs)
Time frame: Up to day 44
Incidence of AEs leading to discontinuation
Time frame: Up to day 44
Number of participants with a clinically significant change from baseline in vital signs
Time frame: Up to day 21
Number of participants with a change from baseline in 12-lead ECG results
Time frame: Up to day 21
Number of participants with physical examination abnormalities
Time frame: Up to day 21
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to day 20
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to day 20
Apparent total body clearance (CLT/F)
Time frame: Up to day 20
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 29 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/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 Deucravacitinib and Famotidine 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 29 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 20). 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 29 Apr 2025.