Renal InsufficiencyPhase 1NCT05718843

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

A Phase 1 study testing BI 425809 in people with Renal Insufficiency, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin is a medicine that is being developed to treat diseases of the brain. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency
What is being tested?: BI 425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteGermany
Study dates: 1 Feb 2023to 24 Oct 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female participants
Age of at least 18 years (inclusive)
BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Male participants are not required to use contraception
Woman of childbearing potential (WOCP) 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:

Show all 22Show fewer

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
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 sterilised (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 Units per Litre (U/L) and oestradiol below 30 nanogram per Litre (ng/L) is confirmatory)
Inclusion criteria applying only to participants with impaired renal function
Renal impairment based on assessment of estimated Glomerular Filtration Rate (eGFR) at screening (severe renal impairment: 15-29 millilitre per minute per 1.73 square metre (mL/min/1.73 m2), moderate renal impairment: 30-59 mL/min/1.73 m2, mild renal impairment: 60-89 mL/min/1.73 m2)
Chronic renal impairment > 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening)
Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and check-in, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal impairment
Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor
Inclusion criteria applying only to participants with normal renal function
Individually matched to participants with renal impairment according to sex, age, and weight, and race
eGFR ≥ 90 mL/min/1.73 m2
Absence of clinically significant abnormalities identified by a detailed medical history, full physical examination, vital signs and 12-lead ECG at both screening and check-in visits
Absence of clinically significant abnormalities identified by a laboratory test at screening visit

Who cannot join

Any evidence of a concomitant disease assessed as clinically relevant by the investigator
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)
History of relevant orthostatic hypotension, fainting spells, or blackouts
Relevant chronic or acute infections
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin

Show all 23Show fewer

History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days (or 5 of its half-lives, whichever is longer) of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause ECG interval from the start of the QRS complex to the end of the T wave (QT interval) / QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc interval) prolongation ) Further exclusion criteria apply.
Exclusion criteria applying only to participants with renal impairment
A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening
Acute renal failure or active nephritis
Nephrotic syndrome
Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease
Relevant diseases for which it can be assumed that the absorption of the study drugs will not be normal (i.e., relevant malabsorption, chronic diarrhoea)
Participant under dialysis or planned to start dialysis during participation in the study
History of myocardial infarction, cerebrovascular accident or severe arrhythmia within the 6 months prior to the screening visit.
History of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing Further exclusion criteria apply.
Exclusion criteria applying only to participants with normal renal function
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg) (for participants older than 60 years: 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 (beats per minute) bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Kiel GmbH
Kiel, 24105

Other trials in Germany

About this study

Official title: Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe, Moderate and Mild) Compared With Matched Male and Female Participants With Normal Renal Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.

Iclepertin is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having kidney 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 this time, they visit the study site 6 times. For one of the visits, participants stay 4 nights at the study site. 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: Renal Insufficiency
Being tested: BI 425809
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 425809Drug
Also called Iclepertin
Iclepertin orally as film-coated tablet.

Study groups in NCT05718843
Study group	Role	What they receive
Iclepertin - Mild renal impairment	Experimental	Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h). Receives: Drug: BI 425809
Iclepertin - Moderate renal impairment	Experimental	Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h). Receives: Drug: BI 425809
Iclepertin - Severe renal impairment	Experimental	Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h). Receives: Drug: BI 425809
Iclepertin - Normal renal impairment	Experimental	Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h). Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment. Each participant with normal renal function could be matched to multiple participants with renal impairment across groups but was to be matched to only 1 participant within a renal impairment group. Receives: Drug: BI 425809

What is being measured

The primary outcome is the main question the study is designed to answer.

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) is reported.
Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Measured: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
Maximum measured concentration of Iclepertin in plasma (Cmax) is reported.
Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Measured: Within 2 hours (h) prior to drug administration 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 and 144 h after 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-∞)
Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Measured: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202324 Oct 2023

First posted8 Feb 2023
Study start1 Feb 2023
Primary completion24 Oct 2023
Study completion24 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Non-randomised, single dose, open-label, individual-matched design.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05718843
Sponsor's protocol ID: 1346-0047
Other IDs: 2022-002739-74
Status last verified: Oct 2025
First submitted: 30 Jan 2023
Last updated: 30 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Publications

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.
PubMed 41903096

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe, Moderate and Mild) Compared With Matched Male and Female Participants With Normal Renal Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)
ClinicalTrials.gov ID: NCT05718843
Acronym / sponsor ID: 1346-0047
Conditions: Renal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Feb 2023 (actual)
Primary completion: 24 Oct 2023 (actual)
Study completion: 24 Oct 2023 (actual)
First posted: 8 Feb 2023 (actual)
Results: Posted 30 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Non-randomised, single dose, open-label, individual-matched design.

Arm	Type	Receives
Iclepertin - Mild renal impairment	Experimental	Drug: BI 425809Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Iclepertin - Moderate renal impairment	Experimental	Drug: BI 425809Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Iclepertin - Severe renal impairment	Experimental	Drug: BI 425809Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Iclepertin - Normal renal impairment	Experimental	Drug: BI 425809Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h). Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment. Each participant with normal renal function could be matched to multiple participants with renal impairment across groups but was to be matched to only 1 participant within a renal impairment group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Male or female participants
Age of at least 18 years (inclusive)
BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Male participants are not required to use contraception

Key exclusion criteria (23 listed)

Any evidence of a concomitant disease assessed as clinically relevant by the investigator
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)
History of relevant orthostatic hypotension, fainting spells, or blackouts
Relevant chronic or acute infections

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 425809Also: IclepertinIclepertin orally as film-coated tablet.	Drug	Iclepertin - Mild renal impairment, Iclepertin - Moderate renal impairment, Iclepertin - Normal renal impairment, Iclepertin - Severe renal impairment

Primary outcome

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: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.
Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
Time frame: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.
Maximum measured concentration of Iclepertin in plasma (Cmax) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.

1 secondary outcome

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.

Results and safety

Results posted to the registry on 30 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iclepertin - Mild Renal Impairment	8	8
Iclepertin - Moderate Renal Impairment	8	8
Iclepertin - Severe Renal Impairment	8	8
Iclepertin - Normal Renal Impairment	12	12

Primary outcome: 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: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.. Geometric least squares mean (Standard Error). Unit: Hours * nanomoles / Liter

Measure	Iclepertin - Mild Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Mild Renal Impairment n = 8	Iclepertin - Moderate Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment n = 7	Iclepertin - Severe Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Severe Renal Impairment n = 7
Value	5014.15 (NA)	4702.56 (NA)	5099.51 (NA)	5320.64 (NA)	6526.38 (NA)	5175.78 (NA)

Iclepertin - Mild Renal Impairment vs Iclepertin - Normal Renal Function Matched to Mild Renal Impairment: Ratio of adjusted geometric means [%]: 106.63 (90% CI 81.09 to 140.20)
Iclepertin - Moderate Renal Impairment vs Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment: Ratio of adjusted geometric means [%]: 95.84 (90% CI 79.43 to 115.64)
Iclepertin - Severe Renal Impairment vs Iclepertin - Normal Renal Function Matched to Severe Renal Impairment: Ratio of adjusted geometric means [%]: 126.09 (90% CI 104.08 to 152.77)

Population analysed: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the treated set (TS) who provided at least one primary or secondary pharmacokinetic (PK) endpoint and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was included in the PKS even if he/she contributed with only 1 PK parameter value to the statistical assessment.

Primary outcome: Maximum Measured Concentration of Iclepertin in Plasma (Cmax)

Measure	Iclepertin - Mild Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Mild Renal Impairment n = 8	Iclepertin - Moderate Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment n = 7	Iclepertin - Severe Renal Impairment n = 8	Iclepertin - Normal Renal Function Matched to Severe Renal Impairment n = 7
Value	145.06 (NA)	139.86 (NA)	177.03 (NA)	150.83 (NA)	146.15 (NA)	152.00 (NA)

Iclepertin - Mild Renal Impairment vs Iclepertin - Normal Renal Function Matched to Mild Renal Impairment: Ratio of adjusted geometric means [%]: 103.72 (90% CI 76.35 to 140.90)
Iclepertin - Moderate Renal Impairment vs Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment: Ratio of adjusted geometric means [%]: 117.37 (90% CI 101.29 to 136.00)
Iclepertin - Severe Renal Impairment vs Iclepertin - Normal Renal Function Matched to Severe Renal Impairment: Ratio of adjusted geometric means [%]: 96.15 (90% CI 77.84 to 118.77)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iclepertin - Mild Renal Impairment	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Iclepertin - Moderate Renal Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Iclepertin - Severe Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): Participant recruitment was ended when 36 participants were entered into the trial and treated with Iclepertin. Participant recruitment was ended because the obtained sample size was deemed adequate to evaluate the trial endpoints. Trial was completed according to protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41903096Choi 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 425809 in people with Renal Insufficiency, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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: Within 2 hours (h) prior to drug administration 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 and 144 h after drug administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05718843, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.