Trial Outcomes & Findings for A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems (NCT NCT05731895)

Last Updated: 2026-04-24

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

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.

Results posted on

2026-04-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	13	8	8
Overall Study COMPLETED	13	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iclepertin - Control - Normal Hepatic Function n=13 Participants 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.	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n=8 Participants 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.	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n=8 Participants 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.	Total n=29 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 9.4 • n=2 Participants	65.0 years STANDARD_DEVIATION 4.8 • n=1 Participants	59.3 years STANDARD_DEVIATION 5.4 • n=3 Participants	62.2 years STANDARD_DEVIATION 7.5 • n=24 Participants
Sex: Female, Male Female	7 Participants n=2 Participants	3 Participants n=1 Participants	5 Participants n=3 Participants	15 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=2 Participants	5 Participants n=1 Participants	3 Participants n=3 Participants	14 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	13 Participants n=2 Participants	8 Participants n=1 Participants	8 Participants n=3 Participants	29 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: 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.

Population: 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.

Outcome measures

Outcome measures
Measure	Iclepertin - Child-Pugh A - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n=8 Participants 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.	Iclepertin - Child-Pugh B - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n=8 Participants 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.
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	5329.59 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12	4812.01 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12	4090.68 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.09	5264.70 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.09

PRIMARY outcome

Timeframe: 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). 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'.

Outcome measures

Outcome measures
Measure	Iclepertin - Child-Pugh A - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n=8 Participants 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.	Iclepertin - Child-Pugh B - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n=8 Participants 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.
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)	121.00 nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12	123.48 nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12	112.71 nanomole/Liter Standard Error na Adjusted geometric standard error = 1.08	92.26 nanomole/Liter Standard Error na Adjusted geometric standard error = 1.08

SECONDARY outcome

Timeframe: 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.

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'.

Outcome measures

Outcome measures
Measure	Iclepertin - Child-Pugh A - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n=8 Participants 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.	Iclepertin - Child-Pugh B - Control - Normal Hepatic Function n=8 Participants 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.	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n=8 Participants 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.
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	6140.01 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.13	5428.52 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.13	4503.14 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12	7078.07 hour*nanomole/Liter Standard Error na Adjusted geometric standard error = 1.12

Adverse Events

Iclepertin - Child-Pugh A - Control - Normal Hepatic Function

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Iclepertin - Child-Pugh A - Mild Hepatic Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Iclepertin - Child-Pugh B - Control - Normal Hepatic Function

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Iclepertin - Child-Pugh B - Moderate Hepatic Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Iclepertin - Child-Pugh A - Control - Normal Hepatic Function n=8 participants at risk 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.	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n=8 participants at risk 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.	Iclepertin - Child-Pugh B - Control - Normal Hepatic Function n=8 participants at risk 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.	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n=8 participants at risk 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.
Nervous system disorders Headache	25.0% 2/8 • 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.	0.00% 0/8 • 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.	37.5% 3/8 • 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.	12.5% 1/8 • 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.
Investigations Amylase increased	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.	0.00% 0/8 • 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.
Investigations Lipase increased	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.	0.00% 0/8 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • 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.	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.
Vascular disorders Hypertension	0.00% 0/8 • 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.	0.00% 0/8 • 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.	12.5% 1/8 • 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.	0.00% 0/8 • 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.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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