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

NCT07837115 — Phase 1, Not yet recruiting, 24 participants, Celgene

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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

Registry	NCT07837115
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Celgene (Industry)
Conditions	Healthy Volunteers
Interventions	Irafamdastat (Drug)
Dates	start 2026-10-06 (estimated), primary completion 2026-12-19 (estimated), completion 2026-12-19 (estimated), first posted 2026-09-23, last updated 2026-09-23
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions
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

Irafamdastat (Drug), also known as BMS-986368, CC-97489: Specified dose on specified days.

+Outcome measures

Primary outcomes

Maximum observed plasma concentration (Cmax) [Up to Day 19]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to Day 19]
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to Day 19]

Secondary outcomes

Time of maximum observed plasma concentration (Tmax) [Up to Day 19]
Terminal elimination half-life (T-HALF) [Up to Day 19]
Apparent total body clearance (CLT/F) [Up to Day 19]
Volume of distribution of terminal phase (Vz/F) [Up to Day 19]
Number of participants with adverse events (AEs) [Up to Day 28 days after last dose]
Number of participants with serious AEs (SAEs) [Up to Day 28 days after last dose]
Number of participants with vital sign abnormalities [Up to Day 21]
Number of participants with physical examination abnormalities [Up to Day 21]
Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 21]
Number of participants with clinical laboratory abnormalities [Up to Day 18]
Number of participants with treatment-emergent suicidal ideation and behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) [Up to Day 21]
Change in anziety as assessed by Beck Anxiety Inventory (BAI) [Up to Day 21]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy male or non-pregnant and non-nursing female (as assigned at birth).
* BMI between 18.0 and 33.0 kg/m2, inclusive.

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Local Institution - 0001	Anaheim, California	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb