A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07295951
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 14C-bleximenib — DRUG
    14C-bleximenib will be administered orally.
  • bleximenib — DRUG
    Non-radiolabeled bleximenib will be administered orally.

Study Details

The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).

Key Dates

First listed
Dec 22, 2025
Start date
Nov 18, 2025
Status verified
Jun 2026
Primary completion
Jun 14, 2026
Completion
Jul 13, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bleximenib
    Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate.

Primary Outcome Measure

Percentage of Dose Excreted in Urine (feu) [ Time Frame: Up to Day 28 ]

Central Contacts

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