Healthy ParticipantsPhase 1NCT07225647
A Study to Assess the Effect of Food on the Drug Levels of Admilparant
A Phase 1 study testing Admilparant in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess the effect of food on the drug levels of Admilparant 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?
- Admilparant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2025to 5 Jan 2026
- 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 have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.
Who cannot join
- Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participants must not have had any previous exposure to Admilparant.
- Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0002
Lenexa, Kansas, 66219-9746
Local Institution - 0001
Salt Lake City, Utah, 84124-1365
About this study
Official title: An Open-Label, Randomized, Two-part Study in Healthy Participants to Assess the Food Effect on the Pharmacokinetics of Admilparant To-Be-Marketed Tablet Formulations
The purpose of this study is to assess the effect of food on the drug levels of Admilparant
- Conditions
- Healthy Participants
- Being tested
- Admilparant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdmilparantDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment A | Experimental | Not described Receives: Drug: Admilparant |
| Part 1: Treatment B | Experimental | Not described Receives: Drug: Admilparant |
| Part 2: Treatment C | Experimental | Not described Receives: Drug: Admilparant |
| Part 2: Treatment D | Experimental | Not described Receives: Drug: Admilparant |
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 13 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to 13 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to 13 days
Secondary outcomes (9)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 13 days
Terminal half-life (T-HALF)
Measured: Up to 13 days
Apparent total body clearance (CLT/F)
Measured: Up to 13 days
Apparent volume of distribution (Vz/F)
Measured: Up to 13 days
Number of participants with adverse events (AEs)
Measured: Up to 13 days
Number of participants with a change in clinical laboratory values
Measured: Up to 13 days
Number of participants with a change in vital sign measurements
Measured: Up to 13 days
Number of participants with a change in physical examination results
Measured: Up to 13 days
Number of participants with a change in 12-lead electrocardiogram (ECG) results
Measured: Up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start7 Nov 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
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
- 56 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
- NCT07225647
- Sponsor's protocol ID
- IM027-1052
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2025
- Last updated
- 14 Jan 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/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-part Study in Healthy Participants to Assess the Food Effect on the Pharmacokinetics of Admilparant To-Be-Marketed Tablet Formulations
- ClinicalTrials.gov ID
- NCT07225647
- Acronym / sponsor ID
- IM027-1052
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 10 Nov 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 assess the effect of food on the drug levels of Admilparant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment A | Experimental | Drug: Admilparant |
| Part 1: Treatment B | Experimental | Drug: Admilparant |
| Part 2: Treatment C | Experimental | Drug: Admilparant |
| Part 2: Treatment D | Experimental | Drug: Admilparant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.
Key exclusion criteria (4 listed)
- Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participants must not have had any previous exposure to Admilparant.
- Participants must not have a history of any severe drug allergy or drug reaction (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 |
|---|---|---|
| AdmilparantSpecified dose on specified days | Drug | Part 1: Treatment A, Part 1: Treatment B, Part 2: Treatment C, Part 2: Treatment D |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 13 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 13 days
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 13 days
9 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 13 days
Terminal half-life (T-HALF)
Time frame: Up to 13 days
Apparent total body clearance (CLT/F)
Time frame: Up to 13 days
Apparent volume of distribution (Vz/F)
Time frame: Up to 13 days
Number of participants with adverse events (AEs)
Time frame: Up to 13 days
Number of participants with a change in clinical laboratory values
Time frame: Up to 13 days
Number of participants with a change in vital sign measurements
Time frame: Up to 13 days
Number of participants with a change in physical examination results
Time frame: Up to 13 days
Number of participants with a change in 12-lead electrocardiogram (ECG) results
Time frame: Up to 13 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 14 Jan 2026.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Admilparant in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites 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 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 13 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 14 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.