account_circleRecruiting
Healthy participants
Bayer Identifier:
23182
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
AllAge
18 - 55 YearsTrial summary
Enrollment Goal
40Trial Dates
August 2026 - October 2026Phase
Phase ICould I Receive a placebo
NoProducts
Sevabertinib, BAY 2927088Accepts Healthy Volunteer
YesWhere to participate
| Status | Institution | Location |
|---|---|---|
Recruiting | Clinical Pharmacology of Miami - Oncology | Miami, 33172, United States |
Primary Outcome
- AUC (Area Under the Curve) of metforminAssessed 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 metforminAssessed 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 metforminAssessed 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-RandomizedBlinding
Open LabelAssignment
Single GroupTrial Arms
1