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, 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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Irafamdastat

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
      • Contact: Judith Cabrera, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: Irafamdastat; Specified dose on specified days.; Other Names: BMS-986368; CC-97489
Experimental: Treatment C	Drug: Irafamdastat; Specified dose on specified days.; Other Names: BMS-986368; CC-97489
Experimental: Treatment A	Drug: Irafamdastat; Specified dose on specified days.; Other Names: BMS-986368; CC-97489
Experimental: Treatment D	Drug: Irafamdastat; Specified dose on specified days.; Other Names: BMS-986368; CC-97489
Experimental: Treatment E	Drug: Irafamdastat; Specified dose on specified days.; Other Names: BMS-986368; CC-97489

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 21
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 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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• <p>BMS Clinical Trial Information</p>

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2026
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: phase 1; healthy volunteers; relative bioavailability; food effect; healthy participants; CC-97489; BMS-986368; Irafamdastat
• Other Study ID Numbers: IM045-1016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No