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

Part of paid clinical trials in Anaheim, California.

Sponsor
Celgene
Study ID
NCT07837115
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Irafamdastat — DRUG
    Specified dose on specified days.

Study Details

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.

Key Dates

First listed
Sep 23, 2026
Start date
Oct 6, 2026
Status verified
Sep 2026
Primary completion
Dec 19, 2026
Completion
Dec 19, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
  • Experimental: Treatment B
  • Experimental: Treatment C
  • Experimental: Treatment D
  • Experimental: Treatment E

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 19 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001AnaheimCalifornia92801
Site 0001

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Local Institution - 0001· Anaheim, CA

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