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Completed

NCT Number: NCT05661344

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

applicable to all participants

  • 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.

Inclusion criteria

applying only to participants with impaired hepatic function

  • Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
  • further inclusion criteria apply

Inclusion criteria

applying only to participants with normal hepatic function

  • Individually matched to participants with hepatic impairment according to sex, age, and weight
  • further inclusion criteria apply

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 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
  • further exclusion criteria apply

Exclusion criteria

applying only to participants with hepatic impairment

  • 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
  • further exclusion criteria apply

Exclusion criteria

applying only to participants with normal hepatic function

  • 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
  • further exclusion criteria apply

Treatment and study plan

BI 1015550

Drug

BI 1015550

Other names: Nerandomilast, JASCAYD®

Primary outcomes

  1. 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)

    Time frame: 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.

    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.

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

    Time frame: 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 (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.

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-∞)

    Time frame: 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.

    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 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 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics, Safety and Tolerability of BI 1015550 Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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