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Healthy participants from United States for Breast Cancer

Phase 1

Recruiting

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.

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC of midazolam when given with and without BAY2927088

Cmax of midazolam when given with and without BAY2927088

Secondary outcome measures

Number of participants with TEAEs

Severity of TEAEs

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

Midazolam

2018

Completed Phase 4

~1910

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,762 Total Patients Enrolled

20 Trials studying Breast Cancer

128,370 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being actively enrolled in this research study?

"Indeed, information from clinicaltrials.gov shows that this investigation is presently enrolling participants. The trial was first listed on April 17th, 2024 and last revised on April 19th, 2024. Enrollment aims to recruit a total of 15 individuals at one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"Indeed, information available on clinicaltrials.gov indicates that this research study is actively seeking eligible participants. The trial was initially listed on April 17th, 2024 and the most recent update occurred on April 19th, 2024. A total of 15 individuals are sought for enrollment at a single designated site."

Answered by AI

What are the potential risks of involving healthy participants from the United States in this study?

"The safety rating for healthy individuals from the United States in this trial is a 1, as it is categorized as a Phase 1 study with minimal available data on both safety and efficacy."

Answered by AI