Please sign in to follow a disease.
Could a cancer drug alter Metformin's effects? a trial investigates
NCT ID NCT07753252
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy participants are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Clinical Pharmacology of Miami - Oncology
Miami, Florida, 33172, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Does it matter where you inject? scientists test Weight-Loss drug in arm, thigh, and belly
- New drug RO7830698 put to the test for COPD
- Three pill versions of one drug go head to head in the bloodstream
- Pfizer tests RSV vaccine aimed at older adults
- Radioactive tracer maps where a new drug goes in the body
- Radioactive tag lets scientists follow an experimental drug through the human body