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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176536
Recruitment Status : Active, not recruiting
First Posted : November 25, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Chronic Kidney Disease Drug: BI 764198 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : November 17, 2020
Estimated Study Completion Date : November 17, 2020

Arm Intervention/treatment
Experimental: All participants Drug: BI 764198
Capsules




Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 96 hours ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 96 hours ]

Secondary Outcome Measures :
  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) [ Time Frame: Up to 96 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

    -- 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%)

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
    • 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)
  • eGFR calculated by CKD-EPI formula ≥60 mL/min/1.73m² and < 30 mL/min/1.73m² for Group 1 and ≥30 mL/min/1.73m² and < 15 mL/min/1.73m² for Group 2

For all subjects:

  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except 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
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 30 days of planned administration of investigational drug in the current trial, or longer if required by local regulation, or within 5 half-lives of the investigational agent taken (whichever is longer) or concurrent participation in another clinical trial in which investigational drug is administered
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Inability to refrain from smoking on specified trial days
  • Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
  • Drug abuse or positive drug screening
  • Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  • Inability to comply with the dietary regimen of the trial site
  • A marked baseline 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
  • A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

Female subjects will not be allowed to participate, if any of the following apply:

  • Positive pregnancy test, pregnancy, or plans to become pregnant within 30 days after study completion
  • Lactation

Male subjects will not be allowed to participate, if any of the following apply:

  • Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
  • positive test indicating an ongoing infection with SARS-CoV-2 and clinical symptoms suggestive of the disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176536


Locations
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Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04176536    
Other Study ID Numbers: 1434-0002
2019-003744-69 ( EudraCT Number )
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency