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

NCT05661344 | Completed Phase 1 Results

• 2 other identifiers: 1305-00272022-002811-45
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver 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 liver problems. Liver problems may change how a medicine is processed in the body. 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 liver problems. The doctors also check participants' health and take note of any unwanted effects.

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 enantiomer, determined using the chiral bioanalytical 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 the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups.

  Within the 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 and 144 hours after drug administration.

• Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)

  Maximum measured concentration of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical 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 the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale. The model was fitted separately for the two hepatic impaired groups.

  Within the 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 and 144 hours after drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within the 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 and 144 hours after drug administration.

Study Arms (3)

BI 1015550 mild hepatic impairment

EXPERIMENTAL

Participants with mild hepatic impairment, classified as Child-Pugh A (score 5 to 6 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours.

Drug: BI 1015550

BI 1015550 moderate hepatic impairment

EXPERIMENTAL

Participants with moderate hepatic impairment, classified as Child-Pugh B (score 7 to 9 points), administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours.

Drug: BI 1015550

BI 1015550 normal hepatic function

EXPERIMENTAL

Participants with normal hepatic function administered orally one film-coated tablet of 18 milligram of BI 1015550 with 240 milliliter of water after an overnight fast of at least 10 hours. Participants with normal hepatic function were individually matched to participants with mild and/or moderate hepatic impairment. The matching criteria were age (± 10 years), sex and weight (± 15%). One participant with normal hepatic function could match one participant in one or both groups of participants with hepatic impairment.

Drug: BI 1015550

Interventions

BI 1015550 DRUG

BI 1015550

Also known as: Nerandomilast, JASCAYD®

BI 1015550 mild hepatic impairment; BI 1015550 moderate hepatic impairment; BI 1015550 normal hepatic function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants
• Age 18-79 years (inclusive)
• Body Mass Index (BMI) of 18.5 to 35 kilogram per square meter (kg/m2) (inclusive)
• Signed and dated written informed consent in accordance with Guideline for Guideline for Good Clinical Practice - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Male participants are not required to use contraception
• Women of childbearing potential 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. Methods of contraception considered adequate for female participants of childbearing potential are listed in the protocol.
• Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
• Individually matched to participants with hepatic impairment according to sex, age, and weight

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 pharmacokinetic(s) (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 or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix
• A marked prolongation of time from the start of the Q wave to the end of the T wave (QT)/ QT corrected for heart rate (QTc) interval (such as QT Corrected by the Fridericia Formula (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant Electrocardiogram (ECG) finding at screening
• Any finding in the medical examination (including blood pressure (BP), pulse rate (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 Links

• Related Info

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

BI 1015550

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

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

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 22, 2022
• Study Start: February 7, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: November 28, 2025
• Results First Posted: November 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)