Status:
COMPLETED
A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants
Lead Sponsor:
Bayer
Conditions:
Advanced Non-small Cell Lung Cancer
EGFR Mutation
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06221475
Start Date
January 25 2024
End Date
May 8 2024
Last Update
June 28 2024
Active Locations (1)
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1
ICON plc
Groningen, Netherlands, 9728NZ