account_circleRecruiting

Healthy participants

Phase 1 study in healthy adults to see how sevabertinib changes metformin levels in the body

Trial purpose

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 Participants Requirements

Sex

All

Age

18 - 55 Years

Trial summary

Enrollment Goal
40
Trial Dates
August 2026 - October 2026
Phase
Phase I
Could I Receive a placebo
No
Products
Sevabertinib, BAY 2927088
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
Clinical Pharmacology of Miami - OncologyMiami, 33172, United States

Primary Outcome

  • AUC (Area Under the Curve) of metformin
    Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
    date_rangeTime 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
    Assessed for metformin with and without sevabertinib (Metformin alone vs Metformin + sevabertinib).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    Relative to metformin administration on Study Day 1 un until Study Day 4

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    From the start of study intervention until the last follow-up visit, up to 7 days after the last administration of study intervention.

Trial design

Phase 1, open-label, fixed-sequence crossover study to investigate the effect of sevabertinib on the pharmacokinetics of metformin in healthy participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-Randomized
Blinding
Open Label
Assignment
Single Group
Trial Arms
1