Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced. The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine * Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 2 treatment groups. In Group 1, participants will take: * BAY2927088 as a single dose on Days 1 and 8. * Itraconazole once daily on Days 5 to 11. In Group 2, participants will take: * BAY2927088 as a single dose on Days 1 and 14. * Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2. Participants will visit the study clinic: * at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study * on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2 * once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up During the study, the doctors and their study team will: * perform physical examinations * collect blood samples from the participants to measure the levels of BAY2927088 * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Oral
Capsule, 100 mg, oral.
Tablet, 100 mg, 200mg and 300mg, oral.
Parexel Baltimore - Early Phase Clinical Unit
Baltimore, Maryland, United States
AUC of BAY2927088 with and without itraconazole
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
Cmax of BAY2927088 with and without itraconazole
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-5, pre-dose of Day 8, multiple post-dose time points of Days 8-12
AUC of BAY2927088 with and without carbamazepine
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-3; pre-dose of Day 14, multiple post-dose time points of Days 14-16
Cmax of BAY2927088 with and without carbamazepine
Time frame: Pre-dose of Day 1, multiple post-dose time points of Days 1-3; pre-dose of Day 14, multiple post-dose time points of Days 14-16
Number of participants with TEAEs
Time frame: After the first administration of study intervention up to 7 days after the last administration of study intervention.
Severity of TEAEs
Time frame: After the first administration of study intervention up to 7 days after the last administration of study intervention.
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