NCT07102095View on ClinicalTrials.gov

A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 24, 2025

Primary Completion Date

January 23, 2026

Study Completion Date

January 23, 2026

Conditions
Hepatic InsufficiencyLiver DiseasesPharmacokineticsDrug Metabolism
Interventions
DRUG

Sevabertinib

Single oral dose of 20 mg sevabertinib administered as 2 x 10 mg film-coated tablets

Trial Locations (2)

32809

RECRUITING

Orlando Clinical Research Center, Orlando

33014

RECRUITING

Clinical Pharmacology of Miami, LLC - Oncology Department, Miami

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
lead

Bayer

INDUSTRY