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NCT Number: NCT07837115

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Anaheim, California, 92801, United States

Location contact

Site 0001

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irafamdastat

Drug

Specified dose on specified days.

Other names: BMS-986368, CC-97489

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 19

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 19

  3. 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

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 19

  2. Terminal elimination half-life (T-HALF)

    Time frame: Up to Day 19

  3. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 19

  4. Volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Day 19

  5. Number of participants with adverse events (AEs)

    Time frame: Up to Day 28 days after last dose

  6. Number of participants with serious AEs (SAEs)

    Time frame: Up to Day 28 days after last dose

  7. Number of participants with vital sign abnormalities

    Time frame: Up to Day 21

  8. Number of participants with physical examination abnormalities

    Time frame: Up to Day 21

  9. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 21

  10. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 18

  11. 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

  12. Change in anziety as assessed by Beck Anxiety Inventory (BAI)

    Time frame: Up to Day 21

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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