Search / Trial NCT06221475

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

Launched by BAYER · Jan 15, 2024

Trial Information

Current as of October 07, 2024

Completed

Keywords

Nsclc Tki

Description

No description provided

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • * Capable of giving signed informed consent
  • * Participant must be 18 or age of legal maturity to 55 years of age inclusive, at the time of signing the informed consent
  • * Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac, and neurologic examination
  • * Body mass index (BMI) within the range \[18 - 30\] kg/m\^2 (inclusive), with bodyweight above/equal to 50 kg
  • * Male
  • * Study participants of reproductive potential must agree to use adequate contraception when sexually active during the study period and for at least 3 months after the last dose of study intervention, and refrain from donating sperm during this period
  • * Participant must have venous access sufficient to allow blood sampling as required by the protocol
  • * Participant must be willing to undergo multiple blood draws as required by the protocol
  • * Participant must be willing to comply with dietary and fluid requirements during the treatment period (including abstaining from alcohol use)
  • * Ability to understand and follow study-related instructions
  • Exclusion Criteria:
  • * Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus)
  • * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal
  • * Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator
  • * A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator
  • * Known history of hypersensitivity (or known allergic reaction) to BAY2927088-related compounds, or any components of the formulation
  • * History of known or suspected malignant tumors
  • * Participants with any type of psychiatric disorder, especially any mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent
  • * Any condition which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 3 days) constipation or symptomatic prostatic hypertrophy
  • * Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton \[excluding spinal column\]), during work or during participation in a clinical study in the period of 1 year prior to screening
  • * Participant will be excluded when he participated in another study with a radiation burden of 0.1 - 1 mSv (inclusive) in the period of 1 year prior to screening; 1.1 - 2 mSv (inclusive) in the period of 2 years prior to screening; 2.1 - 3 mSv (inclusive) in the period of 3 years prior to screening, etc. (add 1 year per 1 mSv)

About Bayer

Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.

Locations

Groningen, , Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0