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.
Age range
18 Years – 55 Years
Sex
MALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
For Part 1: Absolute bioavailability (F) as percent F (%F) after oral administration as oral to IV ratio of AUC/D (Area under the concentration curve per dose)
Timeframe: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: AUC of BAY2927088 and [14C]-BAY2927088
Timeframe: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: AUC/D of BAY2927088 and [14C]-BAY2927088
Timeframe: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: Cmax (maximum concentration) of BAY2927088 and [14C]-BAY2927088
Timeframe: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 1: Cmax/D of BAY2927088 and [14C]-BAY2927088
Timeframe: Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
For Part 2: Amount of BAY2927088 and its metabolites excreted in urine (%AEur), in feces (%AEfec), and in vomit as a percent of the dose (%AEvom, if applicable)
Timeframe: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: AUC of total radioactivity in plasma and whole blood. (AUC(0-tlast) will be used as primary parameter if mean AUC(tlast-∞) >20% of AUC)
Timeframe: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: Cmax of total radioactivity in plasma and whole blood
Timeframe: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: AUC of BAY2927088 in plasma. (AUC[0-tlast] will be used as primary parameter if mean AUC[tlast-∞] >20% of AUC)
Timeframe: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
For Part 2: Cmax of BAY2927088 in plasma
Timeframe: Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose