Healthy VolunteersPhase 1NCT07837115
A Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat in Healthy Adult Participants
A Phase 1 study testing Irafamdastat in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of irafamdastat and to assess food-effect on the pharmacokinetics (PK) of irafamdastat ODT in healthy adult 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?
- Irafamdastat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2026to 19 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy male or non-pregnant and non-nursing female (as assigned at birth).
- BMI between 18.0 and 33.0 kg/m2, inclusive.
Who cannot join
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population at screening and Day 1 predose, confirmed by repeat.
- Other protocol-defined Inclusion/Exclusion criteria apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United States1 site, 1 recruiting
- Recruiting
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, 92801
Judith Cabrera, Site 0001
About this study
Official title: A Phase 1, Open-label, Randomized, Single-dose Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) Oral Disintegrating Tablet, Oral Disintegrating Tablet Suspension, and Capsule Sprinkles to the Reference Capsule and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat Administered as Oral Disintegrating Tablet in Healthy Adult Participants
The purpose of this study is to evaluate the relative bioavailability of irafamdastat and to assess food-effect on the pharmacokinetics (PK) of irafamdastat ODT in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Irafamdastat
- Keywords
- BMS-986368, Irafamdastat, relative bioavailability, food effect, phase 1, healthy participants, healthy volunteers, CC-97489
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrafamdastatDrug
Also called BMS-986368, CC-97489
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Irafamdastat |
| Treatment B | Experimental | Not described Receives: Drug: Irafamdastat |
| Treatment C | Experimental | Not described Receives: Drug: Irafamdastat |
| Treatment D | Experimental | Not described Receives: Drug: Irafamdastat |
| Treatment E | Experimental | Not described Receives: Drug: Irafamdastat |
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 19
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 19
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 19
Secondary outcomes (12)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 19
Terminal elimination half-life (T-HALF)
Measured: Up to Day 19
Apparent total body clearance (CLT/F)
Measured: Up to Day 19
Volume of distribution of terminal phase (Vz/F)
Measured: Up to Day 19
Number of participants with adverse events (AEs)
Measured: Up to Day 28 days after last dose
Number of participants with serious AEs (SAEs)
Measured: Up to Day 28 days after last dose
Number of participants with vital sign abnormalities
Measured: Up to Day 21
Number of participants with physical examination abnormalities
Measured: Up to Day 21
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 21
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 18
Number of participants with treatment-emergent suicidal ideation and behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 21
Change in anziety as assessed by Beck Anxiety Inventory (BAI)
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start6 Oct 2026
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
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 CelgeneThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT07837115
- Sponsor's protocol ID
- IM045-1016
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single-dose Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) Oral Disintegrating Tablet, Oral Disintegrating Tablet Suspension, and Capsule Sprinkles to the Reference Capsule and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat Administered as Oral Disintegrating Tablet in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07837115
- Acronym / sponsor ID
- IM045-1016
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986368, Irafamdastat, relative bioavailability, food effect, phase 1, healthy participants, healthy volunteers, CC-97489
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 23 Sep 2026 (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 relative bioavailability of irafamdastat and to assess food-effect on the pharmacokinetics (PK) of irafamdastat ODT in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Irafamdastat |
| Treatment B | Experimental | Drug: Irafamdastat |
| Treatment C | Experimental | Drug: Irafamdastat |
| Treatment D | Experimental | Drug: Irafamdastat |
| Treatment E | Experimental | Drug: Irafamdastat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or non-pregnant and non-nursing female (as assigned at birth).
- BMI between 18.0 and 33.0 kg/m2, inclusive.
Key exclusion criteria (2 listed)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population at screening and Day 1 predose, confirmed by repeat.
- 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 |
|---|---|---|
| IrafamdastatAlso: BMS-986368, CC-97489Specified dose on specified days. | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 19
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 19
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 19
12 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 19
Terminal elimination half-life (T-HALF)
Time frame: Up to Day 19
Apparent total body clearance (CLT/F)
Time frame: Up to Day 19
Volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 19
Number of participants with adverse events (AEs)
Time frame: Up to Day 28 days after last dose
Number of participants with serious AEs (SAEs)
Time frame: Up to Day 28 days after last dose
Number of participants with vital sign abnormalities
Time frame: Up to Day 21
Number of participants with physical examination abnormalities
Time frame: Up to Day 21
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 21
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 18
Number of participants with treatment-emergent suicidal ideation and behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 21
Change in anziety as assessed by Beck Anxiety Inventory (BAI)
Time frame: Up to Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
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 Irafamdastat in people with Healthy Volunteers, run by Celgene 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 2 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to Day 19). 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 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.