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A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems

Primary Purpose

Liver Diseases, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BI 690517
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases

Eligibility Criteria

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

Inclusion Criteria: Male or female subjects aged at least 18 years at screening Body mass index of 18.5 to 36.0 kg/m2 (inclusive) Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. 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) Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electric Cardiogram, and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment. Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor. Inclusion criteria applying only to healthy participants with normal hepatic function: Healthy subjects according to the following criteria: the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Individually matched to participants with hepatic impairment according to sex, age, and weight Exclusion Criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator Repeated measurements of blood pressure and pulse rate out of range considered clinically significant by the investigator Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, except for laboratory values outside the reference range due to underlying disease Any evidence of a concomitant disease assessed as clinically relevant by the investigator Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair) Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders History of relevant orthostatic hypotension, fainting spells, or blackouts Relevant chronic or acute infections Further exclusion criteria apply

Sites / Locations

  • Omega Research Orlando, LLC
  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BI 690517 mild hepatic impairment (Child-Pugh A)

BI 690517 normal hepatic function

BI 690517 moderate hepatic impairment (Child-Pugh B)

Arm Description

control group

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 8, 2023
Last Updated
May 3, 2023
Sponsor
Boehringer Ingelheim
Collaborators
IQVIA global CRO
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1. Study Identification

Unique Protocol Identification Number
NCT05731908
Brief Title
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
Official Title
Pharmacokinetics, Safety, and Tolerability of BI 690517 in Subjects With Mild and Moderate Liver Impairment (Child-Pugh Classification A and B) as Compared to Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
IQVIA global CRO

4. Oversight

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

5. Study Description

Brief Summary
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Healthy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BI 690517 mild hepatic impairment (Child-Pugh A)
Arm Type
Experimental
Arm Title
BI 690517 normal hepatic function
Arm Type
Experimental
Arm Description
control group
Arm Title
BI 690517 moderate hepatic impairment (Child-Pugh B)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 690517
Intervention Description
BI 690517
Primary 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 4 days
Title
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame
Up to 4 days
Secondary 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 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged at least 18 years at screening Body mass index of 18.5 to 36.0 kg/m2 (inclusive) Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. 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) Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electric Cardiogram, and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment. Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor. Inclusion criteria applying only to healthy participants with normal hepatic function: Healthy subjects according to the following criteria: the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Individually matched to participants with hepatic impairment according to sex, age, and weight Exclusion Criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator Repeated measurements of blood pressure and pulse rate out of range considered clinically significant by the investigator Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, except for laboratory values outside the reference range due to underlying disease Any evidence of a concomitant disease assessed as clinically relevant by the investigator Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair) Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders History of relevant orthostatic hypotension, fainting spells, or blackouts Relevant chronic or acute infections Further exclusion criteria apply
Facility Information:
Facility Name
Omega Research Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

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
Related Info

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A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems

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