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Healthy participants from United States for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participant is a nonsmoker who has not used tobacco- or nicotine- containing products (eg., nicotine patch) for at least 6 months before administration of the first study intervention.
Must not have
History of known or suspected malignant tumors.
Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease, renal diseases), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose up to 24 hours post-dose on day 1 (period 1), day 3 (period 2) and day 14 (period 3)
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new treatment, BAY2927088, for advanced non-small cell lung cancer with specific genetic changes. The study involves healthy participants to understand how the treatment affects the levels

Who is the study for?
Healthy adults aged 18-55, with a BMI of 18.0 to 30 kg/m^2 and weighing at least 50 kg can join this study. Participants must not smoke or use nicotine for six months prior, women should be non-childbearing, and men must agree to contraception during the study.
What is being tested?
The trial is testing BAY2927088's effect on how the body processes Midazolam—a drug broken down by liver enzymes—in healthy participants over three periods involving single and multiple doses of BAY2927088.
What are the potential side effects?
Potential side effects are not specified but will include any medical problems experienced during the trial. These could range from minor issues like headaches or nausea to more serious conditions related to organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I haven't smoked or used nicotine products for at least 6 months.
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My BMI is between 18 and 30, and I weigh at least 50 kg.
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I am a woman who cannot become pregnant, not pregnant, and not breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cancer.
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I have significant health issues like heart, liver, kidney diseases, diabetes, or seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose up to 24 hours post-dose on day 1 (period 1), day 3 (period 2) and day 14 (period 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose up to 24 hours post-dose on day 1 (period 1), day 3 (period 2) and day 14 (period 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC of midazolam when given with and without BAY2927088
Cmax of midazolam when given with and without BAY2927088
Secondary study objectives
Number of participants with TEAEs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy participants from United StatesExperimental Treatment2 Interventions
The healthy volunteers will be confined to the clinic throughout the intervention period of the study. The study includes visits during screening, intervention, and follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2927088
2024
Completed Phase 1
~90
Midazolam
2018
Completed Phase 4
~1910

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,270 Previous Clinical Trials
25,508,717 Total Patients Enrolled
~10 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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