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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

RecruitingPhase 1Healthy volunteers welcome

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

Who can join

Ages 18 to 55 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Celgene · Participants: 24 · Started: Oct 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07837115

Locations in the U.S.

CaliforniaCenExel ACT (Formerly Anaheim Clinical Trials; LLC), Anaheim

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.