A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants

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 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.

Conditions

• Advanced Non-small Cell Lung Cancer
• EGFR Mutation
• HER2 Mutation
• Healthy Volunteers

Interventions

DRUG

BAY2927088

Oral

DRUG

Itraconazole

Capsule, 100 mg, oral.

DRUG

Carbamazepine

Tablet, 100 mg, 200mg and 300mg, oral.

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-10

Primary Completion

2024-06-12

Completion

2024-06-12

FDA Drug

Yes

Countries

• United States

Study Locations