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

Hepatic Insufficiency Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661344
• Other study ID #: 1305-0027
• Secondary ID: 2022-002811-45
• Status: Completed
• Phase: Phase 1
• Start date: February 7, 2023
• Est. completion date: September 13, 2023

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 taken up in the blood.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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. 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 or intrauterine hormone-releasing system

• 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 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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• BI 1015550
BI 1015550

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 7 days
Primary	Maximum measured concentration of the analyte in plasma (Cmax)		up to 7 days
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 7 days

External Links

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