Phase 1
N=20
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
Renal Insufficiency · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03302091 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24) — 3.97; 7.88 nanomole*hour/Liter (nmol*h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 1467335 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24) |
3.97; 7.88 | — |
| PRIMARY Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax) |
3.03; 6.01 | — |
| PRIMARY Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28) |
692.42; 1566.88 | — |
| PRIMARY Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28) |
100.57; 141.20 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14) |
321.23; 532.06 | — |
| SECONDARY Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14) |
73.41; 94.28 | — |
Summary
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
Eligibility Criteria
Inclusion Criteria
- Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, 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 CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2
- Age of 18 to 79 years (incl.)
- BMI of 18.5 to 34 kg/m2 (incl.)
- 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 (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:
- Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)
- Hormonal intrauterine device
- Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)
- A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)
- Surgically sterilised (including bilateral tubal occlusion, hysterectomy)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion Criteria
Healthy subjects
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged 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 judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula < 90 mL/min/1.73m2
Subjects with moderate renal impairment
- Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:
- puts the subjects at risk because of participation 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 these criteria.
- Any finding of the medical examination (including BP, PR and ECG) of clinical relevance
- 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 all subjects
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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 ortho
Data sourced from ClinicalTrials.gov (NCT03302091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.