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In Part 1, participants will receive a single dose of 40 mg of BAY2927088 as oral tablets on Study Day 1 approximately 30 min after a light meal, they will then receive a single dose of a microtracer not exceeding 100 ug of \[14C\]-BAY2927088 and 37 kilo becquerel (kBq) \[1000 nano Curie (nCi)\] of 14C will be administered intravenously (IV) as a 15 min infusion ending at the expected median time to maximum concentration (tmax) for the tablet (2 hours oral post-dose). After 2 days of washout, participants will move on to Part 2. In Part 2, on Study Day 1 approximately 30 min after a light meal, all enrolled participants will receive a single dose of 40 mg BAY2927088 containing approximately 3.7 MBq (100 µCi) \[14C\]-BAY 2927088 administered as an oral solution

4 coated tablets (10 mg) per single dose 30 min after a light meal

BAY2927088 coated tablet 10 mg

IV infusion 15 min ending at 2 hours oral post-dose

[14C]-BAY2927088 solution for infusion

[14C]-BAY2927088 oral solution

Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body.

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment works by blocking the mutated EGFR and HER2 protein present in NSCLC cells and may help stop the further spread of NSCLC.

BAY2927088 is under development, once it is approved, it may help treat people with NSCLC.

The participants of this study will be healthy men and will have no benefit from the administration of BAY2927088. However, the study will provide important information for the design of subsequent studies with BAY2927088 in people with NSCLC.

The participants in this study will get the non-radiolabeled and radio-labeled study treatment BAY2927088 in the form of tablets and solution by mouth and as an intravenous infusion in the arm. By radiolabeling the study treatment, researchers can track its movement and breakdown in the body of the participants. During the study, the study team will do physical examinations, take medical history, ask the participants questions about their smoking or alcohol consumption habits and other medications used, check vital signs such as blood pressure, heart rate, body temperature and the number of breaths taken per minute (respiratory rate), take blood and urine samples, do HIV (human immunodeficiency virus), hepatitis and optional COVID-19 tests per local regulations, and examine heart health using electrocardiogram (ECG).

Each study participant will go through a first test phase (screening) of up to 28 days before the start of treatment. The study will have two parts. In part 1, the study participants will take a single dose of the non-radiolabeled study treatment in the form of tablets by mouth 30 minutes following a light meal. They will then receive the radiolabeled study treatment as an intravenous infusion in the arm over 15 minutes. After 2 days of washout, the same group of participants will move on to Part 2 of the study. They will take a single dose of the radio-labeled study treatment as a solution by mouth 30 minutes after a light meal. The participants and the study team know what treatment the participants will take. The total duration of the study will be approximately 8 weeks per participant, including an in house stay of approximately 23 days and 22 nights. There will be a final examination on the last day of their in-house stay before the participants are discharged and go home.

The study doctors and their team will contact the participant to learn about the participant's health until the participant completes the study.

This is a single-arm open-label, single dose study in healthy male participants

A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants

A Two-part, Single Center, Open-label Study to Investigate the Pharmacokinetics, Metabolic Disposition, Mass Balance and Absolute Bioavailability of BAY 2927088 in Healthy Male Participants

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Based on radioactivity excreted in urine and feces, and vomit as a percentage of the dose to assess mass balance of total radioactivity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants	NCT06221475	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 coat... [14C]-BAY292708... [14C]-BAY292708...	18 Years - 55 Years	Bayer
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants	NCT06221475	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 coat... [14C]-BAY292708... [14C]-BAY292708...	18 Years - 55 Years	Bayer

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