Phase 1 Study in Healthy Adults to See How Sevabertinib Changes Metformin Levels in the Body

August 4, 2026 updated by: Bayer

Phase 1, Open-label, Fixed-sequence Crossover Study to Investigate the Effect of Sevabertinib on the Pharmacokinetics of Metformin in Healthy Participants

This Phase 1 study in healthy adults looks at whether sevabertinib changes how the body handles metformin. The study is based on the idea that sevabertinib may block kidney transporters (proteins that move medicines) called MATE1 and MATE2-K, which help remove metformin from the body. Each participant receives a single dose of metformin alone, and later receives sevabertinib for several days and then takes metformin again while still taking sevabertinib. The study aims to learn how metformin, gets into, moves through, and out of the body when it is administered with sevabertinib. This is called "Pharmacokinetics". Furthermore, the study will help us learn about the safety and tolerability of sevabertinib and metformin when given alone or in combination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33172
        • Clinical Pharmacology of Miami - Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metformin + Sevabertinib
Single 500 mg oral dose of metformin on Day 1 (Intervention Period 1) in healthy participants. Sevabertinib pre-treatment period (days -4 to -1) when sevabertinib is administered alone. Single 500 mg oral dose of metformin co-administered during ongoing sevabertinib 20 mg BID regimen on Day 1 of Intervention Period 2; sevabertinib continued on Day 2
Drug: Metformin
Immediate-release tablet, 500 mg; administered as a single 500 mg oral dose in Intervention Period 1 (Day 1) and as a single 500 mg oral dose in Intervention Period 2 (Day 1 of the combination phase, after sevabertinib pre-treatment)
Drug: Sevabertinib (BAY 2927088)
Film-coated tablet, 10 mg; administered as 20 mg BID (oral) pre-treatment in Intervention Period 2 and continued 20 mg BID during co-administration with metformin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC (Area Under the Curve) of metformin
Time Frame: Relative to metformin administration on Study Day 1 un until Study Day 4
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Relative to metformin administration on Study Day 1 un until Study Day 4
AUC(0-tlast) (Area Under the Curve from time 0 to tlast) of metformin
Time Frame: Relative to metformin administration on Study Day 1 un until Study Day 4
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Relative to metformin administration on Study Day 1 un until Study Day 4
Cmax (Maximum Plasma Concentration) of metformin
Time Frame: Relative to metformin administration on Study Day 1 un until Study Day 4
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Relative to metformin administration on Study Day 1 un until Study Day 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.
The number of participants with TEAEs will be summarized by study intervention using Medical Dictionary for Regulatory Activities (MedDRA) terms.
From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.
Severity of treatment-emergent adverse events (TEAEs)
Time Frame: From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.
Intensity of AEs should be documented using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.5.0).
From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.

As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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