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

NCT05718843 | Completed Phase 1 Results

• 2 other identifiers: 1346-00472022-002739-74
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

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

  Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) 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.

  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.

  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-∞)

  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.

Study Arms (4)

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).

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).

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).

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.

Drug: BI 425809

Interventions

BI 425809 DRUG

Iclepertin orally as film-coated tablet.

Also known as: Iclepertin

Iclepertin - Mild renal impairment; Iclepertin - Moderate renal impairment; Iclepertin - Normal renal impairment; Iclepertin - Severe renal impairment

Eligibility Criteria

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

You may qualify if:

• 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:
• 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)
• 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

You may not qualify if:

• 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
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• 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.
• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

Related Publications (1)

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

  PMID: 41903096 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency

Interventions

BI 425809

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

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.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

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

Study Design

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

Model Details: Non-randomised, single dose, open-label, individual-matched design.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)