search
Back to results

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

Primary Purpose

Hepatic Insufficiency

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 425809 (iclepertin)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Insufficiency

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria Inclusion criteria applicable to all participants: 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). 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 apply Inclusion criteria applying only to participants with normal hepatic function: Individually matched to participants with hepatic impairment according to sex, age, and weight further inclusion criteria apply Exclusion criteria Exclusion criteria applying to all participants: 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 further exclusion criteria apply Exclusion 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 screening further exclusion criteria apply Exclusion 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 investigator further exclusion criteria apply

Sites / Locations

  • CRS Clinical Research Services Kiel GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: Participants with mild hepatic impairment (Child-Pugh A)

Arm 2: Participants with moderate hepatic impairment (Child-Pugh B)

Arm 3: Participants with normal hepatic function individually matched to participants of Arm 1

Arm 4: Participants with normal hepatic function individually matched to participants of Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Maximum measured concentration of iclepertin in plasma (Cmax)

Secondary Outcome Measures

Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Full Information

First Posted
February 8, 2023
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT05731895
Brief Title
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
Official Title
Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Participants with mild hepatic impairment (Child-Pugh A)
Arm Type
Experimental
Arm Title
Arm 2: Participants with moderate hepatic impairment (Child-Pugh B)
Arm Type
Experimental
Arm Title
Arm 3: Participants with normal hepatic function individually matched to participants of Arm 1
Arm Type
Experimental
Arm Title
Arm 4: Participants with normal hepatic function individually matched to participants of Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 425809 (iclepertin)
Intervention Description
BI 425809 (iclepertin)
Primary Outcome Measure Information:
Title
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame
Up to 9 days
Title
Maximum measured concentration of iclepertin in plasma (Cmax)
Time Frame
Up to 9 days
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame
Up to 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Inclusion criteria applicable to all participants: 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). 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 apply Inclusion criteria applying only to participants with normal hepatic function: Individually matched to participants with hepatic impairment according to sex, age, and weight further inclusion criteria apply Exclusion criteria Exclusion criteria applying to all participants: 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 further exclusion criteria apply Exclusion 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 screening further exclusion criteria apply Exclusion 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 investigator further exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs