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

Sponsor
Boehringer Ingelheim
Study ID
NCT05879991
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
May 30, 2023
Start date
Aug 10, 2023
Status verified
Sep 2025
Primary completion
Oct 19, 2023
Completion
Oct 19, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - zongertinib (C-14) (T1)
    Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 \[T1\]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq).
  • Experimental: Part B - zongertinib (T2), then zongertinib (C-14) (R)
    Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 \[T2\]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment \[R\]) via intravenous infusion. The solution contained a mixture of pure \[14C\]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq.

Primary Outcome Measure

Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) [ Time Frame: Within 18 h (urine) or 48 h (faeces) before drug intake; at 0-4, 4-8, 8-12, 12-24 (urine); and at 24 h sampling intervals until 336 h after drug intake (both). Both: after 336 h, every 7 days, up to day 42. Continues in description. ]

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