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

Primary Purpose

Hepatic Insufficiency

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 1015550
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Insufficiency

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CRS Clinical Research Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: participants with mild hepatic impairment (Child-Pugh A)

Group 2: participants with moderate hepatic impairment (Child-Pugh B)

Group 3: participants with normal hepatic function individually matched to participants of Group 1

Group 4: participants with normal hepatic function individually matched to participants of Group 2

Arm Description

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%)

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%)

Outcomes

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)
Maximum measured concentration of the analyte in plasma (Cmax)

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2022
Last Updated
September 22, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05661344
Brief Title
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
September 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: participants with mild hepatic impairment (Child-Pugh A)
Arm Type
Experimental
Arm Title
Group 2: participants with moderate hepatic impairment (Child-Pugh B)
Arm Type
Experimental
Arm Title
Group 3: participants with normal hepatic function individually matched to participants of Group 1
Arm Type
Experimental
Arm Description
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%)
Arm Title
Group 4: participants with normal hepatic function individually matched to participants of Group 2
Arm Type
Experimental
Arm Description
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%)
Intervention Type
Drug
Intervention Name(s)
BI 1015550
Intervention Description
BI 1015550
Primary Outcome Measure Information:
Title
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)
Time Frame
up to 7 days
Title
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Links:
URL
http://www.mystudywindow.com
Description
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A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems

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