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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: Completed Phase 1 study of Healthy Volunteers and Advanced Non-Small-Cell Lung Cancer, sponsored by Bayer.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Healthy Volunteers Advanced Non-Small-Cell Lung Cancer HER2 Mutation EGFR Mutation

Interventions

  • DRUG Esomeprazole
  • DRUG BAY2927088
  • OTHER Food

Study Locations (1)

Maryland

  • Parexel Baltimore - Early Phase Clinical Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2024-03-29
Est. Completion 2024-06-11
Phase Phase 1
Bayer

591 total trials

What the finished NCT06378658 record still lists

NCT06378658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06378658's enrollment target sits among peer trials

21 221st of 283 higher than 63 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06378658, the US trial registry maintained by the National Library of Medicine. NCT06378658 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.