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 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IM045-1016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

BMS-986368; Irafamdastat; relative bioavailability; food effect; phase 1; healthy participants; healthy volunteers; CC-97489

Outcome Measures

Primary Outcomes (3)

• 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 (12)

• 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

Study Arms (5)

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

Interventions

Irafamdastat DRUG

Specified dose on specified days.

Also known as: BMS-986368, CC-97489

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): October 6, 2026
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)