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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003418-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iclepertin | Drug | A single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). 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'. |
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Inclusion criteria
Inclusion criteria applicable to all participants:
The following methods of contraception are considered adequate for female participants of childbearing potential:
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:
Inclusion criteria applying only to participants with normal hepatic function:
Exclusion criteria
Exclusion criteria applying to all participants:
Exclusion criteria applying only to participants with hepatic impairment:
Exclusion criteria applying only to participants with normal hepatic function:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903096 | Derived | 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;26(1):83-100. doi: 10.1007/s40268-026-00537-w. Epub 2026 Mar 28. |
| Label | URL |
|---|---|
| Related Info | View source |
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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
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All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that the participants strictly met all inclusion and none of the exclusion criteria. Participants were not to be entered in the trial if any of the entry criteria were violated.
This was an open-label, non-randomised, single-dose, parallel, individual-matched trial investigating the effect of mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment on the pharmacokinetics (PK) of iclepertin (including its metabolites) following oral administration of a single dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iclepertin - Control - Normal Hepatic Function | 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 impairment (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. |
| FG001 | Iclepertin - Child-Pugh A - Mild Hepatic Impairment | Participants with mild hepatic impairment (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. |
| FG002 | Iclepertin - Child-Pugh B - Moderate Hepatic Impairment | Participants with Moderate hepatic impairment (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated set: All participants who were treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Iclepertin - Control - Normal Hepatic Function | 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 impairment (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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | Pharmacokinetic parameter analysis set (PKS): All participants who were treated with at least 1 dose of trial drug and who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | 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. |
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Adverse events: Up to 11 days following drug administration. All-cause mortality: Up to 19 days following drug administration.
Treated set: All participants who were treated with at least 1 dose of trial drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iclepertin - Child-Pugh A - Control - Normal Hepatic Function | Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with mild hepatic impairment (Child-Pugh A) 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
Small number (8 per group) of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2023 | Feb 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Feb 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
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| 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. |
| BG001 | Iclepertin - Child-Pugh A - Mild Hepatic Impairment | Participants with mild hepatic impairment (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. |
| BG002 | Iclepertin - Child-Pugh B - Moderate Hepatic Impairment | Participants with Moderate hepatic impairment (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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG000 | Iclepertin - Child-Pugh A - Control - Normal Hepatic Function | Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with mild hepatic impairment (Child-Pugh A) 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. |
| OG001 | Iclepertin - Child-Pugh A - Mild Hepatic Impairment | Participants with mild hepatic impairment (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. |
| OG002 | Iclepertin - Child-Pugh B - Control - Normal Hepatic Function | Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with moderate hepatic impairment (Child-Pugh 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. |
| OG003 | Iclepertin - Child-Pugh B - Moderate Hepatic Impairment | Participants with Moderate hepatic impairment (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. |
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|
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| Primary | 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'. | Pharmacokinetic parameter analysis set (PKS): All participants who were treated with at least 1 dose of trial drug and who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non evaluability. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter | 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 | Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). 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'. | Pharmacokinetic parameter analysis set (PKS): All participants who were treated with at least 1 dose of trial drug and who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | 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. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Iclepertin - Child-Pugh A - Mild Hepatic Impairment | Participants with mild hepatic impairment (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. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Iclepertin - Child-Pugh B - Control - Normal Hepatic Function | Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with moderate hepatic impairment (Child-Pugh 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. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | Iclepertin - Child-Pugh B - Moderate Hepatic Impairment | Participants with Moderate hepatic impairment (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. | 0 | 8 | 0 | 8 | 1 | 8 |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Other |
| Analysis of variance (ANOVA) on the logarithmic scale: fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'. Relative bioavailability was estimated by the ratios of the geometric means of the respective pairwise comparison of interest, i.e. for hepatic impairment vs. the respective control group. Additionally, their two-sided 90% confidence intervals (CIs) were provided. This method corresponds to the two one-sided t-test procedure, each at a 5% significance level. | Ratio of adjusted geometric means [%] | 81.86 | 2-Sided | 90 | 67.23 | 99.67 | Ratio [%] = (adjusted geometric mean hepatic impairment / adjusted geometric mean control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 22.6. | Other |
| Other |
| Analysis of variance (ANOVA) on the logarithmic scale: fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'. Relative bioavailability was estimated by the ratios of the geometric means of the respective pairwise comparison of interest, i.e. for hepatic impairment vs. the respective control group. Additionally, their two-sided 90% confidence intervals (CIs) were provided. This method corresponds to the two one-sided t-test procedure, each at a 5% significance level. | Ratio of adjusted geometric means [%] | 157.18 | 2-Sided | 90 | 119.08 | 207.48 | Ratio [%] = (adjusted geometric mean hepatic impairment / adjusted geometric mean control)*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 32.3. | Other |