Recruiting
Phase 1

Sevabertinib with Metformin

Sponsor:

Bayer

Code:

NCT07753252

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Metformin

Sevabertinib (BAY 2927088)

Study Details

Brief summary:

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.

Conditions

Healthy Participants

Study ID

NCT07753252

Start date

Aug 25, 2026

Status verified date

May 13, 2026

Completion date

Oct 22, 2026

Anticipated

Primary completion date

Oct 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

Interventions

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)

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

Primary outcome measure

  • AUC (Area Under the Curve) of metformin [ Time Frame: 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 ]
  • Cmax (Maximum Plasma Concentration) of metformin [ Time Frame: Relative to metformin administration on Study Day 1 un until Study Day 4 ]

Central Contacts and Locations

Central contacts

Therapeutic Area Head

4930300139003clinical-trials-contact@bayer.com

Locations

Clinical Pharmacology of Miami - Oncology

Recruiting

Miami, Florida, United States, 33172

More Information

Sponsor

Bayer

Last update posted

Oct 22, 2026

Last verified

May 13, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Bayer on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.