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NCT06378658 · ClinicalTrials.gov registry record · Phase 1
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 study of Healthy Volunteers and Advanced Non-Small-Cell Lung Cancer, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06378658 is a Phase 1 study of Healthy Volunteers and Advanced Non-Small-Cell Lung Cancer that has completed, run by Bayer. The registered enrollment target is 21 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06378658, a Phase 1 study of Healthy Volunteers and Advanced Non-Small-Cell Lung Cancer, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
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 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 mea
Conditions Studied
Interventions
- DRUG Esomeprazole
- DRUG BAY2927088
- OTHER Food
Study Locations (1)
Maryland
- Parexel Baltimore - Early Phase Clinical Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-03-29 |
| Est. Completion | 2024-06-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06378658
The ClinicalTrials.gov registry entry for NCT06378658 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Esomeprazole is the first listed.
NCT06378658 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06378658 about?
NCT06378658 is a clinical study titled "A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When 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 NCT06378658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-03-29. Estimated completion is 2024-06-11.
What conditions does trial NCT06378658 study?
This clinical trial studies the following conditions: Healthy Volunteers, Advanced Non-Small-Cell Lung Cancer, HER2 Mutation, EGFR Mutation.
What interventions are being tested in trial NCT06378658?
The interventions under investigation include: Esomeprazole (DRUG), BAY2927088 (DRUG), Food (OTHER).
Who is sponsoring clinical trial NCT06378658?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06378658 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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