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Could a cancer drug alter Metformin's effects? a trial investigates

NCT ID NCT07753252

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This Phase 1 study in healthy adults aims to find out whether sevabertinib, an experimental cancer drug, changes how the body processes metformin, a common diabetes medication. Researchers suspect sevabertinib might block kidney transporters that help remove metformin from the body. Participants will receive metformin alone, then again after taking sevabertinib for several days, allowing scientists to compare drug levels and assess safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sevabertinib (BAY 2927088) and metformin
What this could lead to
If sevabertinib is found to affect metformin levels, it could guide dosing recommendations when both drugs are used together, potentially improving safety and effectiveness.
What could go wrong
This is an early-phase study in a small group of healthy volunteers, so results may not reflect real-world patients. The interaction may be minimal or not clinically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, physical examination, 12-lead ECG, and clinical laboratory tests. * Participant is a non-smoker who has not used tobacco- or nicotine-containing products for at least 6 months before the first study intervention administration. * Body mass index (BMI) within the range 18.5 to 30.0 kg/m² (inclusive) and a body weight of at least 50 kg at screening. * Female, of non-childbearing potential only (see Section 10.4.1). Females must not be pregnant or breastfeeding, and must be documented as of non-childbearing potential (WONCBP). A negative pregnancy test is required Exclusion: * Existing relevant diseases of vital organs (e.g., cardiovascular, liver, gastrointestinal, renal, respiratory, or central nervous system diseases) or other organs (e.g., diabetes mellitus). * Known history of hypersensitivity to sevabertinib, metformin, or any of their excipients. * History of known or suspected malignant tumors. * Regular use of medicines within 4 weeks prior to screening. * Administration of strong or moderate inhibitors or inducers of CYP3A4, P-gp, MATE1/2-K, or OCT2 within 4 weeks or 5 half-lives prior to the first study intervention administration, whichever is longer. * Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks or 5 half-lives of the prescription medication prior to the first study intervention administration (whichever is longer), except for occasional use of acetaminophen (up to 2 g/day) within 7 days prior to the first study intervention administration. * Use of supplements or herbal remedies within 2 weeks prior to the first study intervention administration, except for vitamins. * Excessive intake of methylxanthine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of methylxanthine is defined as the regular consumption of more than 600 mg of caffeine per day (e.g., \>5 cups of coffee) or would likely be unable to refrain from the use of methylxanthine-containing beverages and food during confinement at the clinic. * Clinically relevant findings in the ECG such as a second- or third-degree atrio-ventricular block, prolongation of the average QRS complex over 120 msec or of the QTc (Fridericia correction) interval over 450 msec or any other finding which in the opinion of the investigator will hinder participant's safety at screening or check-in (Day-1). * Positive results for hepatitis B virus surface antigen, hepatitis B virus core antibody, hepatitis C virus antibodies, human immunodeficiency virus antibodies 1 and/or 2 at screening. * Estimated creatinine clearance \<90 mL/min according to Cockcroft-Gault formula (at screening). * Positive urine drug and cotinine screening at screening or check-in (Day-1). * Positive urine alcohol test at screening or check-in (Day-1). * Unable/unwilling to comply with study restrictions.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinical Pharmacology of Miami - Oncology

    Miami, Florida, 33172, United States

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