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A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1810631 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability of BI 1810631 Administered as Film-coated Tablet Together With an Intravenous Microtracer Dose of BI 1810631 (C-14) (Part B) in Healthy Male Volunteers

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Trial Profile

A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1810631 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability of BI 1810631 Administered as Film-coated Tablet Together With an Intravenous Microtracer Dose of BI 1810631 (C-14) (Part B) in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jun 2025

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At a glance

  • Drugs Zongertinib (Primary) ; Zongertinib (Primary) ; Zongertinib
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 30 Apr 2025 Results assessing the absorption, distribution, metabolism and excretion (ADME) of zongertinib (Part A) and the absolute bioavailability (F) of oral zongertinib compared with intravenous (IV) microtracer infusion (Part B), in healthy male volunteers were presented at the 116th Annual Meeting of the American Association for Cancer Research
  • 23 Oct 2023 Status changed from active, no longer recruiting to completed.
  • 20 Sep 2023 Status changed from recruiting to active, no longer recruiting.

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