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NCT06360211 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT06360211 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 15 participants.
The verdict
NCT06360211, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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
Interventions
- DRUG Midazolam
- DRUG BAY2927088
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06360211
The ClinicalTrials.gov registry entry for NCT06360211 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT06360211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06360211 about?
NCT06360211 is a clinical study titled "A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants". 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 th...
What is the current status of trial NCT06360211?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-04-17. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT06360211?
The interventions under investigation include: Midazolam (DRUG), BAY2927088 (DRUG).
Who is sponsoring clinical trial NCT06360211?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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