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

StatusRecruiting
PhasePhase 1
SponsorBayer
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Sep 21, 2026 → Oct 22, 2026
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Primary completion pushed from Sep 21, 2026 to Oct 22, 2026
    • Study completion date: Sep 28, 2026 to Oct 22, 2026
    • Start date changed from estimate of Aug 21, 2026 to Aug 25, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Bayer
131 trials monitored
See 16 trials at risk
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.
Trial Details
NCT Number NCT07753252
Lead Sponsor Bayer
Conditions
(from sponsor)		 Healthy Participants
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov