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A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BI 764198 in Subjects With Moderate and Severe Renal Impairment in Comparison to Subjects With Normal Renal Function (a Mono-centric, Open-label Study With Matched-pair Design)

NCT04176536•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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)
+2 more criteria

Exclusion Criteria

•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
+30 more criteria

Locations (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Key Dates

Start Date

December 10, 2019

Primary Completion Date

November 17, 2020

Completion Date

November 17, 2020

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

HealthyChronic Kidney Disease

Interventions

BI 764198

DRUG

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Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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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: December 19, 2020Data 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 in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

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