PAREXEL International Early Phase Clinical Unit (London)
Harrow, HA1 3UJ, United Kingdom
NCT Number: NCT06329895
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.
Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood.
The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088:
* Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of the drug in participants' blood
In this study, participants will take the following treatments:
* Dabigatran in the morning of Day 1 and 9. * Rosuvastatin in the morning of Day 3 and 12. * BAY2927088 two times a day in the morning and evening of Days 6 to 15.
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 16 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 dabigatran, rosuvastatin 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. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Harrow, HA1 3UJ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration.
Oral administration.
Oral administration.
Time frame: Pre-dose on Day 1 and 9, multiple post-dose time points on Day 1-2 and Day 9-11 and one time point on Day 3 and Day 12
Cmax: Maximum observed drug concentration
Time frame: Pre-dose on Day 1 and 9, multiple post-dose time points on Day 1-2 and Day 9-11 and one time point on Day 3 and Day 12
AUC: Area under the concentration vs time curve
Time frame: Pre-dose on Day 3, Day 12, multiple timepoints on Day 3-5, Day 12-15, one timepoint on Day 6 and Day 16
Time frame: Pre-dose on Day 3, Day 12, multiple timepoints on Day 3-5, Day 12-15, one timepoint on Day 6 and Day 16
Time frame: Up to 7 days after the last administration of study intervention
Time frame: Up to 7 days after the last administration of study intervention
Bayer
Industry
A Phase 1, Open Label, Fixed Sequence, Crossover Study to Investigate the Effect of BAY 2927088 on the Pharmacokinetics of Dabigatran Etexilate or Rosuvastatin in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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