Healthy ParticipantsPhase 1NCT05901714
A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam
A Phase 1 study testing Afimetoran, Phenytoin and Midazolam in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2). 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?
- Afimetoran, Phenytoin and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 11 Apr 2024
- 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
- Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.
Who cannot join
- Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.
- History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.
- Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
- Conditions
- Healthy Participants
- Being tested
- Afimetoran, Phenytoin, Midazolam
- Keywords
- BMS-986256, Afimetoran, Midazolam, CYP3A4, Phenytoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimetoranDrug
Also called BMS-986256
Specified dose on specified days
PhenytoinDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Afimetoran followed by phenytoin + afimetoran | Experimental | Not described Receives: Drug: Afimetoran; Drug: Phenytoin |
| Part 2: Midazolam followed by afimetoran + midazolam | Experimental | Not described Receives: Drug: Afimetoran; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Parts 1 and 2
Measured: Up to 53 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Parts 1 and 2
Measured: Up to 53 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Parts 1 and 2
Measured: Up to 53 days
Secondary outcomes (8)
Time to attain maximum observed plasma concentration (Tmax)
Parts 1 and 2
Measured: Up to 53 days
Terminal half-life (T-Half)
Parts 1 and 2
Measured: Up to 53 days
Apparent total body clearance of the drug from the plasma (CLT/F)
Parts 1 and 2
Measured: Up to 53 days
Number of participants with adverse events (AEs)
Parts 1 and 2
Measured: Up to 124 days
Number of participants with clinical laboratory abnormalities
Parts 1 and 2
Measured: Up to 66 days
Number of participants with physical examination abnormalities
Parts 1 and 2
Measured: Up to 66 days
Number of participants with vital sign abnormalities
Parts 1 and 2
Measured: Up to 66 days
Number of participants with electrocardiogram (ECG) abnormalities
Parts 1 and 2
Measured: Up to 66 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start14 Jun 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
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
- 65 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
- NCT05901714
- Sponsor's protocol ID
- IM026-026
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)
- ClinicalTrials.gov ID
- NCT05901714
- Acronym / sponsor ID
- IM026-026
- Conditions
- Healthy Participants
- Keywords
- BMS-986256, Afimetoran, Midazolam, CYP3A4, Phenytoin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 13 Jun 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.
This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Afimetoran followed by phenytoin + afimetoran | Experimental | Drug: Afimetoran, Drug: Phenytoin |
| Part 2: Midazolam followed by afimetoran + midazolam | Experimental | Drug: Afimetoran, Drug: Midazolam |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.
- History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.
- Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.
- 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 |
|---|---|---|
| AfimetoranAlso: BMS-986256Specified dose on specified days | Drug | Part 1: Afimetoran followed by phenytoin + afimetoran, Part 2: Midazolam followed by afimetoran + midazolam |
| PhenytoinSpecified dose on specified days | Drug | Part 1: Afimetoran followed by phenytoin + afimetoran |
| MidazolamSpecified dose on specified days | Drug | Part 2: Midazolam followed by afimetoran + midazolam |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 53 days
Parts 1 and 2
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time frame: Up to 53 days
Parts 1 and 2
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 53 days
Parts 1 and 2
8 secondary outcomes
Time to attain maximum observed plasma concentration (Tmax)
Time frame: Up to 53 days
Terminal half-life (T-Half)
Time frame: Up to 53 days
Apparent total body clearance of the drug from the plasma (CLT/F)
Time frame: Up to 53 days
Number of participants with adverse events (AEs)
Time frame: Up to 124 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 66 days
Number of participants with physical examination abnormalities
Time frame: Up to 66 days
Number of participants with vital sign abnormalities
Time frame: Up to 66 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 66 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 7 Aug 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers 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 Afimetoran, Phenytoin and Midazolam 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 1 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 7 Aug 2024. 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 53 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 7 Aug 2024.