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NCT05731895
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
Conditions: Hepatic Insufficiency
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: Boehringer Ingelheim
Summary
This study is open to people with and without liver problems.
People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of the brain.
The purpose of this study is to find out whether having liver problems influences how iclepertin is taken up in the body.
All participants take iclepertin once as a tablet.Participants are in the study for 2 to 3 weeks.
During the first part of the study, they stay at the study site for 4 nights.
Afterwards, there are 5 visits to the study site and 1 call.
The site staff measures the amount of iclepertin in the blood.
The doctors also regularly check participants' health and take note of any unwanted effects.
Eligibility Criteria
Inclusion criteriaInclusion criteria applicable to all participants:Male or female participantsAge 18-79 years (inclusive)Body Mass Index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m2) (inclusive)Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trialMale participants are not required to use contraceptionWomen of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after trial completion.The following methods of contraception are considered adequate for female participants of childbearing potential:Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condomUse of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condomUse of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)Sexually abstinent (true abstinence, in line with the preferred and usual lifestyle of the subject) - -A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.Female participants are not considered to be of childbearing potential if they are either surgically sterilized (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle-stimulating hormone (FSH) above 40 unit per liter (U/L) and oestradiol below 30 nanogram per liter (ng/L) is confirmatory).Inclusion criteria applying only to participants with impaired hepatic function:Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child Pugh B (score 7-9 points)further inclusion criteria applyInclusion criteria applying only to participants with normal hepatic function:Individually matched to participants with hepatic impairment according to sex, age, and weightfurther inclusion criteria applyExclusion criteriaExclusion criteria applying to all participants:Any evidence of a concomitant disease assessed as clinically relevant by the investigatorFor diabetics only: uncontrolled diabetes mellitus with a glycated hemoglobin (HbA1c) > 9Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics (PK) of the trial medication (except appendectomy or simple hernia repair)Diseases of the Central Nervous System (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or history of suicide attempts)History of relevant orthostatic hypotension, fainting spells, or blackoutsRelevant chronic or acute infectionsfurther exclusion criteria applyExclusion criteria applying only to participants with hepatic impairment:A marked prolongation of the time from the start of the Q wave to the end of the T wave (QT)/ Corrected QT (QTc) interval (such as QTc Fridericia (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other clinically relevant electrocardiogram (ECG) finding at screeningfurther exclusion criteria applyExclusion criteria applying only to participants with normal hepatic function:Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigatorfurther exclusion criteria apply
Source: ClinicalTrials.gov (NCT05731895). StuddyBuddy aggregates publicly available trial information.