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COMPLETEDPHASE1

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

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)

NCT05718843•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
+10 more criteria

Exclusion Criteria

•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)
•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
+9 more criteria

Locations (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Key Dates

Start Date

February 1, 2023

Primary Completion Date

October 24, 2023

Completion Date

October 24, 2023

Last Updated

November 18, 2023

Enrollment

ACTUAL participants

Conditions

Renal Insufficiency

Interventions

BI 425809

DRUG

Product Surveillance Registry

NCT01524276

Cardiac Rhythm DisordersUrological Disorders+14 more

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RECRUITINGPHASE1

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

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Renal Insufficiency Chronic

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Product Surveillance Registry

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

Evaluation of Children With Endocrine and Metabolic-Related Conditions

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Amino Acid Loss During Continuous Renal Replacement Therapy

Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial