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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05661344

Collaborator

(none)

Enrollment

Arms

4.4

Anticipated Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency	Drug: BI 1015550	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Jan 18, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: participants with mild hepatic impairment (Child-Pugh A)	Drug: BI 1015550 BI 1015550
Experimental: Group 2: participants with moderate hepatic impairment (Child-Pugh B)	Drug: BI 1015550 BI 1015550
Experimental: Group 3: participants with normal hepatic function individually matched to participants of Group 1 One participant with normal hepatic function may match one participant in one or both groups of participants with hepatic impairment. The matching criteria of the participants with normal hepatic function to the participants with hepatic impairment: Age (± 10 years) Gender Weight (± 15%)	Drug: BI 1015550 BI 1015550
Experimental: Group 4: participants with normal hepatic function individually matched to participants of Group 2 One participant with normal hepatic function may match one participant in one or both groups of participants with hepatic impairment. The matching criteria of the participants with normal hepatic function to the participants with hepatic impairment: Age (± 10 years) Gender Weight (± 15%)	Drug: BI 1015550 BI 1015550

Outcome Measures

Primary Outcome Measures

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]
Maximum measured concentration of the analyte in plasma (Cmax) [up to 7 days]

Secondary Outcome Measures

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT05661344

Other Study ID Numbers:

1305-0027
2022-002811-45

First Posted:

Dec 22, 2022

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatic Insufficiency

Liver Failure

Study Results

No Results Posted as of Jan 10, 2023