NCT07295951

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

An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Acute Lymphoblastic Leukemia
• Acute Leukemias
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	14C-bleximenib	14C-bleximenib will be administered orally.
DRUG	bleximenib	Non-radiolabeled bleximenib will be administered orally.

Timeline

• Start date: 2025-11-18
• Primary completion: 2026-06-14
• Completion: 2026-07-13
• First posted: 2025-12-22
• Last updated: 2026-04-13

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study