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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBayer

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Metformin
  • Sevabertinib (BAY 2927088)

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators