Irafamdastat (BMS-986368) relative bioavailability and food effect in healthy adults
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
Run by Celgene · NCT07837115 · Data updated 2026-11-12
This study tests how the body absorbs irafamdastat when taken under different conditions and whether food changes its absorption in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Celgene Industry-sponsored |
| Locations | 1 site (Anaheim, California) |
| Status | Recruiting |
| Started | October 6, 2026 |
| Main results expected | December 19, 2026 |
| Study ends | December 19, 2026 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07837115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults, including males and non-pregnant, non-nursing females, with BMI 18.0–33.0 kg/m2.
✕Probably not a fit
Individuals with organ dysfunction or abnormal screening assessments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, interventional study aims to compare the relative bioavailability of irafamdastat (ODT form) and to examine the effect of food on its pharmacokinetics in healthy volunteers. Participants will receive the drug under specified conditions to measure PK parameters and compare with a reference. The trial will screen healthy adults, confirm normal organ function, and monitor safety through predefined assessments. The study is sponsored by Celgene and conducted at CenExel ACT in Anaheim, CA. Enrollment targets adults who are not pregnant or nursing and meet BMI criteria.
Why it matters
Potential benefit: If successful, findings could inform dosing recommendations for irafamdastat and optimize its administration with or without food.
How similar studies have gone: Prior Phase 1 studies of similar PK/food-effect designs have established feasibility for assessing bioavailability and food impact; this study follows established methods for this drug class.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.