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A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems

Primary Purpose

Renal Insufficiency

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BI 425809
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

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

Inclusion criteria applicable to all participants Male or female participants Age of at least 18 years (inclusive) BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive) Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial Male participants are not required to use contraception Woman of childbearing potential (WOCP) are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after trial completion. 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 (IUD) or intrauterine hormone-releasing system (IUS) 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 renal function Renal impairment based on assessment of estimated Glomerular Filtration Rate (eGFR) at screening (severe renal impairment: 15-29 millilitre per minute per 1.73 square metre (mL/min/1.73 m2), moderate renal impairment: 30-59 mL/min/1.73 m2, mild renal impairment: 60-89 mL/min/1.73 m2) Chronic renal impairment > 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening) Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and check-in, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal 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 participants with normal renal function Individually matched to participants with renal impairment according to sex, age, and weight, and race eGFR ≥ 90 mL/min/1.73 m2 Absence of clinically significant abnormalities identified by a detailed medical history, full physical examination, vital signs and 12-lead ECG at both screening and check-in visits Absence of clinically significant abnormalities identified by a laboratory test at screening visit 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 pharmacokinetics (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 History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) Use of drugs within 30 days (or 5 of its half-lives, whichever is longer) of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause ECG interval from the start of the QRS complex to the end of the T wave (QT interval) / QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc interval) prolongation ) Further exclusion criteria apply. Exclusion criteria applying only to participants with renal impairment A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening Acute renal failure or active nephritis Nephrotic syndrome Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease Relevant diseases for which it can be assumed that the absorption of the study drugs will not be normal (i.e., relevant malabsorption, chronic diarrhoea) Participant under dialysis or planned to start dialysis during participation in the study History of myocardial infarction, cerebrovascular accident or severe arrhythmia within the 6 months prior to the screening visit. History of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing Further exclusion criteria apply. Exclusion criteria applying only to participants with normal renal function Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg) (for participants older than 60 years: 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 (beats per minute) bpm Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Sites / Locations

  • CRS Clinical Research Services Kiel GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: Participants with severe renal impairment

Group 2: Participants with normal renal function individually matched to participants of Group 1

Group 3: Participants with moderate renal impairment

Group 4: Participants with normal renal function matching Group 3

Group 5: Participants with mild renal impairment

Group 6: Participants with normal renal function matching Group 5

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Maximum measured concentration of BI 425809 in plasma (Cmax)

Secondary Outcome Measures

Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

Full Information

First Posted
January 30, 2023
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05718843
Brief Title
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
Official Title
Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe, Moderate and Mild) Compared With Matched Male and Female Participants With Normal Renal Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

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 people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having kidney problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet. Participants are in the study for 2 to 3 weeks. During this time, they visit the study site 6 times. For one of the visits, participants stay 4 nights at the study site. The site staff measures the amount of iclepertin in the blood. The doctors also regularly 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
Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Non-randomised, single dose, open-label, individual-matched design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Participants with severe renal impairment
Arm Type
Experimental
Arm Title
Group 2: Participants with normal renal function individually matched to participants of Group 1
Arm Type
Experimental
Arm Title
Group 3: Participants with moderate renal impairment
Arm Type
Experimental
Arm Title
Group 4: Participants with normal renal function matching Group 3
Arm Type
Experimental
Arm Title
Group 5: Participants with mild renal impairment
Arm Type
Experimental
Arm Title
Group 6: Participants with normal renal function matching Group 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 425809
Other Intervention Name(s)
Iclepertin
Intervention Description
BI 425809
Primary Outcome Measure Information:
Title
Area under the concentration-time curve of BI 425809 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 BI 425809 in plasma (Cmax)
Time Frame
Up to 7 days.
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time Frame
Up to 7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria applicable to all participants Male or female participants Age of at least 18 years (inclusive) BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive) Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial Male participants are not required to use contraception Woman of childbearing potential (WOCP) are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after trial completion. 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 (IUD) or intrauterine hormone-releasing system (IUS) 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 renal function Renal impairment based on assessment of estimated Glomerular Filtration Rate (eGFR) at screening (severe renal impairment: 15-29 millilitre per minute per 1.73 square metre (mL/min/1.73 m2), moderate renal impairment: 30-59 mL/min/1.73 m2, mild renal impairment: 60-89 mL/min/1.73 m2) Chronic renal impairment > 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening) Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and check-in, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal 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 participants with normal renal function Individually matched to participants with renal impairment according to sex, age, and weight, and race eGFR ≥ 90 mL/min/1.73 m2 Absence of clinically significant abnormalities identified by a detailed medical history, full physical examination, vital signs and 12-lead ECG at both screening and check-in visits Absence of clinically significant abnormalities identified by a laboratory test at screening visit 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 pharmacokinetics (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 History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) Use of drugs within 30 days (or 5 of its half-lives, whichever is longer) of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause ECG interval from the start of the QRS complex to the end of the T wave (QT interval) / QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc interval) prolongation ) Further exclusion criteria apply. Exclusion criteria applying only to participants with renal impairment A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening Acute renal failure or active nephritis Nephrotic syndrome Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease Relevant diseases for which it can be assumed that the absorption of the study drugs will not be normal (i.e., relevant malabsorption, chronic diarrhoea) Participant under dialysis or planned to start dialysis during participation in the study History of myocardial infarction, cerebrovascular accident or severe arrhythmia within the 6 months prior to the screening visit. History of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing Further exclusion criteria apply. Exclusion criteria applying only to participants with normal renal function Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg) (for participants older than 60 years: 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 (beats per minute) bpm Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com

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
https://www.mystudywindow.com
Description
Related Info

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A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems

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