Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360211
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-07
Brief Title:
A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 enzymes 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 thanat 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
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 enzymes 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 thanat 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None