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

NCT ID: NCT05879991

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2023-10-19

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

zongertinib (C-14)

Intervention Type: DRUG

Oral solution

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.

Group Type: EXPERIMENTAL

zongertinib

Intervention Type: DRUG

Film-coated tablet

zongertinib (C-14)

Intervention Type: DRUG

Solution for infusion

Interventions

zongertinib (C-14)

Oral solution

Intervention Type: DRUG

zongertinib

Film-coated tablet

Intervention Type: DRUG

zongertinib (C-14)

Solution for infusion

Intervention Type: DRUG

Other Intervention Names

BI 1810631 (C-14), Hernexeos®; BI 1810631, Hernexeos®; BI 1810631 (C-14), Hernexeos®

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

2. Age of 18 to 55 years (inclusive)

3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive)

4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure outside the range of 90 to 145 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2022-503047-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1291-2883

Identifier Type: REGISTRY

Identifier Source: secondary_id

1479-0006

Identifier Type: -

Identifier Source: org_study_id