A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Open Label, Fixed Sequence, Crossover Study to Investigate the Effect of BAY 2927088 on the Pharmacokinetics of Midazolam in Healthy Participants

Status Active, not recruiting

Clinical Trial Summary

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (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 on people with 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.

Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity.

The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088:

• Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time

• Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood

The study will have 3 treatment periods:

Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088

Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic.

Participants will visit the study clinic:

• More than/at least once, within 2 to 28 days before the treatment starts

• Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment

• Once, within 7 to 10 days after they finish treatment for a health checkup

During the study, the doctors and their study team will:

• do physical examinations

• collect blood samples from the participants to measure the blood levels of midazolam and 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. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• EGFR Mutation
• Healthy Volunteers

• NCT number: NCT06360211
• Study type: Interventional
• Source: Bayer
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 17, 2024
• Completion date: June 11, 2024