A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body

NCT04176536 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1434-00022019-003744-69
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal function.

Conditions

Healthy; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

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

  Up to 96 hours

• Cmax (maximum measured concentration of the analyte in plasma)

  Up to 96 hours

Secondary Outcomes (1)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 the last quantifiable data point)

  Up to 96 hours

Study Arms (1)

All participants

EXPERIMENTAL

Drug: BI 764198

Interventions

BI 764198 DRUG

Capsules

All participants

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Despite of moderate and severe renal impairment (Group 1 and Group 2) male or female subjects (at least 25% of each gender) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Estimated Glomerular filtration rate (eGFR) based on Chronic kidney disease (CKD)-EPI formula for Group 1 between 30 and 59 mL/min/1.73m², for Group 2 between 15 and 29 mL/min/1.73m² and for Group 3 ≥90 mL/min/1.73m²
• Age of 18 to 79 years (inclusive)
• Body mass index (BMI) of 18.5 to 34 kg/m\^2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
• Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
• Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• Surgically sterilised (including hysterectomy)
• \-- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulation hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory) Control subjects (Group 3)
• Subjects who can be matched to renal impaired subjects from Group 1 and/or Group 2 based on gender, race, age (within ±10%) and BMI (within ±10%)

You may not qualify if:

• Control subjects:
• Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Estimated Glomerular filtration rate (eGFR) calculated by Chronic kidney disease (CKD)-EPI formula \< 90 mL/min/1.73m²
• Subjects with moderate and severe renal impairment:
• Subject with significant diseases, in the opinion of the investigator, other than moderate or severe renal impairment. A significant disease is defined as a disease which is in the opinion of the investigator:
• puts the subjects at risk by participating in the study
• may influence the results of the study
• may influence the subject's ability to participate in the study
• is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to those criteria.
• Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction
• Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

Related Publications (1)

• Schultz A, Halabi A, Seitz F, Lemmens K, Wulfrath HS, Lobmeyer MT, Retlich S, Choi W, Soleymanlou N. Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment. Expert Opin Investig Drugs. 2025 May;34(5):415-423. doi: 10.1080/13543784.2025.2510673. Epub 2025 Jun 8.

  PMID: 40455255 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: December 10, 2019
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)