A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body

Summary

Part A - the primary objective is to assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects. Part A - the secondary objective is to assess concentrations of BI 1810631 and \[14C\]-radioactivity in plasma. Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer.

Timeline

Start

2023-08-10

Primary completion

2023-10-19

Completion

2023-10-19

Publications

• Grempler R, Joseph D, Gan G, Auclair AM, Tiessen RG, Maw HH, Laux R, Wind S, Roessner PM, Sadrolhefazi B, Muller F, Minich D. Absorption, Metabolism, Distribution and Excretion (ADME) and Absolute Bioavailability Assessment of Zongertinib in Healthy Male Volunteers. Clin Drug Investig. 2026 Feb;46(2):115-125. doi: 10.1007/s40261-025-01509-9. Epub 2025 Dec 5.

Drugs

Indications

No indication recorded.