A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems

Pharmacokinetics, Safety and Tolerability of BI 1015550 Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe and Moderate) as Compared With Individually 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 adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney problems can join the study.

The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without kidney problems. Kidney problems may change how a medicine is taken up in the blood. All participants take a single tablet of BI 1015550.

Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without kidney problems. The doctors also check participants' health and take note of any unwanted effects.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Insufficiency
• Intervention / Treatment: Drug: BI 1015550

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • CRS Clinical Research Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Inclusion criteria applying to all participants:

• Male or female participants
• Age of 18-79 years (inclusive)
• Body mass index (BMI) of 18.5 to 35.0 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Male participants are not required to use contraception
• Women of child-bearing potential (WOCBP) are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 7 days after trial completion.

Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Therefore, 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 liter (U/L) and oestradiol below 30 nanograms/liter (ng/L) is confirmatory).

Further inclusion criteria apply.

Exclusion Criteria:

Exclusion criteria applying to all participants:

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Cholecystectomy or other surgery of the gastrointestinal (GI) tract that could interfere with the pharmacokinetics 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 or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days (or 5 of their half-lives, whichever is longer) of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QT interval corrected for heart rate (QTc) interval prolongation) Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1015550 Severe renal impairment; 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), and not requiring dialysis, administered orally one film-coated tablet of 18 milligram (mg) of BI 1015550 with 240 mL of water after an overnight fast of at least 10 hours (h).	Drug: BI 1015550; BI 1015550; Other Names: Nerandomilast; JASCAYD®
Experimental: BI 1015550 Moderate renal impairment; Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 h.	Drug: BI 1015550; BI 1015550; Other Names: Nerandomilast; JASCAYD®
Experimental: BI 1015550 Normal renal function; Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) administered orally one film-coated tablet of 18 mg of BI 1015550 with 240 mL of water after an overnight fast of at least 10 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 one participant with moderate renal impairment and to one participant with severe renal impairment.	Drug: BI 1015550; BI 1015550; Other Names: Nerandomilast; JASCAYD®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active R-enantiomer, measured by a chiral assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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 BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	Area under the concentration-time curve of BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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 R-BI 1015550 in Plasma (Cmax)	Maximum measured concentration of R-BI 1015550 (the pharmacologically active R-enantiomer, measured by a chiral assay) in plasma (Cmax) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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 BI 1015550 in Plasma (Cmax)	Maximum measured concentration of BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral assay) in plasma (Cmax) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active R-enantiomer, measured by a chiral assay) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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 BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Area under the concentration-time curve of BI 1015550 (mixture of R-(pharmacologically active) and S-(pharmacologically inactive) enantiomers, measured by a non-chiral assay) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. 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. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The ratio of adjusted geometric means is calculated with patients with renal impairment as test groups and their respective matched controls as reference groups.	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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; BI 1015550
• Other Study ID Numbers: 1305-0025; 2022-003080-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No