Healthy ParticipantsPhase 1NCT07753252
Phase 1 Study in Healthy Adults to See How Sevabertinib Changes Metformin Levels in the Body
A Phase 1 study testing Metformin and Sevabertinib (BAY 2927088) in people with Healthy Participants, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Metformin and Sevabertinib (BAY 2927088)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 22 Oct 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Pharmacology of Miami - Oncology
Miami, Florida, 33172
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- Metformin, Sevabertinib (BAY 2927088)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Sevabertinib | Experimental | 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 Receives: Drug: Metformin; Drug: Sevabertinib (BAY 2927088) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area Under the Curve) of metformin
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Measured: 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
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Measured: Relative to metformin administration on Study Day 1 un until Study Day 4
Cmax (Maximum Plasma Concentration) of metformin
Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
Measured: Relative to metformin administration on Study Day 1 un until Study Day 4
Secondary outcomes (2)
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be summarized by study intervention using Medical Dictionary for Regulatory Activities (MedDRA) terms.
Measured: 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)
Intensity of AEs should be documented using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.5.0).
Measured: From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start25 Aug 2026
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a Phase 1, single-center, open-label, non-randomized, fixed sequence, crossover study in healthy participants using an intra-individual comparison (metformin alone vs. metformin with sevabertinib)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753252
- Sponsor's protocol ID
- 23182
- Status last verified
- 13 May 2026
- First submitted
- 4 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
- Expanded access
- Available