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

Part of paid clinical trials in Miami, Florida.

Sponsor
Bayer
Study ID
NCT07753252
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    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 Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 21, 2026
Status verified
Aug 2026
Primary completion
Sep 21, 2026
Completion
Sep 28, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami - OncologyMiamiFlorida33172-

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By research site
Clinical Pharmacology of Miami - Oncology· Miami, FL

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