Recruiting
Phase 1

Irafamdastat

Sponsor:

Celgene

Code:

NCT07837115

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Irafamdastat

Study Details

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

Study ID

NCT07837115

Start date

Oct 6, 2026

Status verified date

Oct, 2026

Completion date

Dec 19, 2026

Anticipated

Primary completion date

Dec 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment A

experimental: Treatment B

experimental: Treatment C

experimental: Treatment D

experimental: Treatment E

Interventions

Irafamdastat

Specified dose on specified days.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

CenExel ACT (Formerly Anaheim Clinical Trials; LLC)

Recruiting

Anaheim, California, United States, 92801

More Information

Sponsor

Celgene

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Celgene on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.