A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems

NCT05731895 | Completed Phase 1 Results

• 2 other identifiers: 1346-00482022-003418-35
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.

  Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

• Maximum Measured Concentration of Iclepertin in Plasma (Cmax)

  Maximum measured concentration of iclepertin in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.

  Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

Study Arms (3)

Iclepertin - Control - normal hepatic function

EXPERIMENTAL

Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with mild or moderate hepatic function (Child-Pugh A or B) and received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. Each control participant with normal hepatic function could be matched to 1 participant in 1 or both groups of participants with hepatic impairment.

Drug: Iclepertin

Iclepertin - Child-Pugh A - Mild hepatic impairment

EXPERIMENTAL

Participants with mild hepatic function (Child-Pugh A) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Drug: Iclepertin

Iclepertin - Child-Pugh B - Moderate hepatic impairment

EXPERIMENTAL

Participants with Moderate hepatic function (Child-Pugh B) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Drug: Iclepertin

Interventions

Iclepertin DRUG

A single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Also known as: BI 425809

Iclepertin - Child-Pugh A - Mild hepatic impairment; Iclepertin - Child-Pugh B - Moderate hepatic impairment; Iclepertin - Control - normal hepatic function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants
• Age 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 trial
• Male participants are not required to use contraception
• Women 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 condom
• Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
• Use 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).
• Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child Pugh B (score 7-9 points)
• Individually matched to participants with hepatic impairment according to sex, age, and weight

You may not qualify if:

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• For diabetics only: uncontrolled diabetes mellitus with a glycated hemoglobin (HbA1c) \> 9
• Cholecystectomy 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 blackouts
• Relevant chronic or acute infections
• 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 screening
• 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 investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

Related Publications (1)

• Choi H, Madari S, Daalman E, English BA, Halabi A, Hohl K, Shatillo Y, Weidinger N, Desch M. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies. Drugs R D. 2026 Mar 28. doi: 10.1007/s40268-026-00537-w. Online ahead of print.

  PMID: 41903096 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

BI 425809

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Limitations and Caveats

Small number (8 per group) of participants.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 16, 2023
• Study Start: March 8, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: April 24, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)