Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Esomeprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal).

Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal).

Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole.

BAY2927088

light low-fat meal or high fat, high calorie meal

Food

Bayer Clinical Trials Contact

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 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.

The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.

The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:

* 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 4 treatment periods:

- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.

On Day 9, participants will take esomeprazole on an empty stomach.

- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.

On Day 13, participants will take esomeprazole on an empty stomach.

Participants will be in this study for about 8 weeks with 3 visits to the study clinic.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment
* once, 7 to 10 days after last dose of BAY2927088, for a health check-up

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

* do 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 of whether they think it is related or not to the study treatment.

A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants

A Phase 1, Open Label, Randomized, Crossover Study to Investigate the Effect of Food and Effect of an Acid Reducing Agent on the Pharmacokinetics of BAY 2927088 in Healthy Participants

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Bayer

Anti-Infective Agents

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Itraconazole

Mitogens

Carbamazepine

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Analgesics, Non-Narcotic

Sodium Channel Blockers

Diuretics, Potassium Sparing

Participant will receive single dose BAY2927088 on Days 1 and 8, will receive itraconazole daily from Day 5 to Day 11.

Participant will receive BAY2927088 single dose on Days 1 and 14, will receive carbamazepine daily from Day 3 to Day 15.

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.

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

A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants

Adjuvants, Anesthesia

Midazolam

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

The healthy volunteers will be confined to the clinic throughout the intervention period of the study. The study includes visits during screening, intervention, and follow-up.

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.

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

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

Cmax: Maximum observed drug concentration

AUC: Area under the concentration vs time curve from zero to infinity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants	NCT06378658	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Esomeprazole Food	18 Years - 55 Years	Bayer
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	NCT06348888	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Itraconazole Carbamazepine	18 Years - 55 Years	Bayer
A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants	NCT06360211	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Midazolam	18 Years - 55 Years	Bayer
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants	NCT06378658	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Esomeprazole Food	18 Years - 55 Years	Bayer

Spots Global Cancer Trial Database for bay2927088

Every month we try and update this database with for bay2927088 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bay2927088

Every month we try and update this database with for bay2927088 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bay2927088 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.