Healthy VolunteersPhase 1NCT05866627
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
A Phase 1 study testing Famotidine and Afimetoran in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy 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 Volunteers
- What is being tested?
- Famotidine and Afimetoran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2023to 29 Sep 2023
- 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
- Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening.
- A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
Who cannot join
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
- GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Local Institution - 0001
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- Famotidine, Afimetoran
- Keywords
- BMS-986256, Famotidine, Gastric pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
Also called Pepcid
Specified dose on specified days
AfimetoranDrug
Also called BMS-986256
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Afimetoran, followed by famotidine + afimetoran | Experimental | Not described Receives: Drug: Famotidine; Drug: Afimetoran |
| Famotidine + afimetoran, followed by afimetoran | Experimental | Not described Receives: Drug: Famotidine; Drug: Afimetoran |
| Afimetoran | Experimental | Not described Receives: Drug: Afimetoran |
| Famotidine, followed by afimetoran | Experimental | Not described Receives: Drug: Famotidine; Drug: Afimetoran |
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 20 Days
Time to attain maximum observed plasma concentration (Tmax)
Measured: Up to 20 Days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Measured: Up to 20 Days
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Measured: Up to 52 Days
Number of participants with clinical laboratory abnormalities
Measured: Up to 52 Days
Number of participants with vital sign abnormalities
Measured: Up to 52 Days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 52 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start4 Jul 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
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
- 32 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
- NCT05866627
- Sponsor's protocol ID
- IM026-1023
- Other IDs
- 1007296
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 13 May 2026
- 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.html
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05866627
- Acronym / sponsor ID
- IM026-1023
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986256, Famotidine, Gastric pH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 19 May 2023 (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 confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Afimetoran, followed by famotidine + afimetoran | Experimental | Drug: Famotidine, Drug: Afimetoran |
| Famotidine + afimetoran, followed by afimetoran | Experimental | Drug: Famotidine, Drug: Afimetoran |
| Afimetoran | Experimental | Drug: Afimetoran |
| Famotidine, followed by afimetoran | Experimental | Drug: Famotidine, Drug: Afimetoran |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening.
- A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
Key exclusion criteria (3 listed)
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
- GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.
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 |
|---|---|---|
| FamotidineAlso: PepcidSpecified dose on specified days | Drug | Afimetoran, followed by famotidine + afimetoran, Famotidine + afimetoran, followed by afimetoran, Famotidine, followed by afimetoran |
| AfimetoranAlso: BMS-986256Specified dose on specified days | Drug | Afimetoran, Afimetoran, followed by famotidine + afimetoran, Famotidine + afimetoran, followed by afimetoran, Famotidine, followed by afimetoran |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 20 Days
Time to attain maximum observed plasma concentration (Tmax)
Time frame: Up to 20 Days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time frame: Up to 20 Days
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 52 Days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 52 Days
Number of participants with vital sign abnormalities
Time frame: Up to 52 Days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 52 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 13 May 2026.
- BMS Clinical Trial InformationLink 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.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 Famotidine and Afimetoran in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 3 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 13 May 2026. 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 Kingdom. 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 20 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 13 May 2026.