A Phase 1 interventional study of Irafamdastat in Healthy Volunteers, sponsored by Celgene. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment
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.
Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted after Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Irafamdastat
Drug: Irafamdastat
Drug: Irafamdastat
Drug: Irafamdastat
Drug: Irafamdastat
Specified dose on specified days.
Also known as: BMS-986368, CC-97489
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
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
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Irafamdastat