check_circleStudy Completed

Advanced non-small cell lung cancer, EGFR mutation, HER2 mutation, Healthy volunteers

A study to learn how BAY2927088 is taken up and handled by the body in healthy male participants

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years

Trial summary

Enrollment Goal
8
Trial Dates
January 2024 - May 2024
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY2927088
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
ICON plcGroningen, 9728NZ, Netherlands

Primary Outcome

  • 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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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)
    Based on radioactivity excreted in urine and feces, and vomit as a percentage of the dose to assess mass balance of total radioactivity
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose

Secondary Outcome

  • Number of participants with treatment-emergent adverse events (TEAE) and severity of treatment-emergent adverse events
    date_rangeTime Frame:
    From dosing up to 15 days after last dosing

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1