Trial Outcomes & Findings for A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems (NCT NCT05718843)
NCT ID: NCT05718843
Last Updated: 2026-03-30
Results Overview
Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Within 2 hours (h) prior to drug administration and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 h after drug administration.
Results posted on
2026-03-30
Participant Flow
This was a non-randomised, single-dose, open-label, parallel, individual-matched design trial. This trial included participants with either impaired or normal renal function who were treated with BI 425809 (Iclepertin).
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that the participants strictly met all inclusion and none of the exclusion criteria. Participants were not to be entered in the trial if any of the entry criteria were violated.
Participant milestones
| Measure |
Iclepertin - Mild Renal Impairment
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Moderate Renal Impairment
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Severe Renal Impairment
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Impairment
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
Each participant with normal renal function could be matched to multiple participants with renal impairment across groups but was to be matched to only 1 participant within a renal impairment group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
12
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
Baseline characteristics by cohort
| Measure |
Iclepertin - Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Impairment
n=12 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
Each participant with normal renal function could be matched to multiple participants with renal impairment across groups but was to be matched to only 1 participant within a renal impairment group.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.6 Years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
71.5 Years
STANDARD_DEVIATION 11.1 • n=28 Participants
|
64.9 Years
STANDARD_DEVIATION 14.6 • n=10 Participants
|
64.3 Years
STANDARD_DEVIATION 9.2 • n=38 Participants
|
67.0 Years
STANDARD_DEVIATION 10.8 • n=33 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
15 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
21 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
8 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
36 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Within 2 hours (h) prior to drug administration and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the treated set (TS) who provided at least one primary or secondary pharmacokinetic (PK) endpoint and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was included in the PKS even if he/she contributed with only 1 PK parameter value to the statistical assessment.
Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Outcome measures
| Measure |
Iclepertin - Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment
n=8 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
5014.15 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
4702.56 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
5099.51 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.11
|
5320.64 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.11
|
6526.38 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.08
|
5175.78 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.08
|
PRIMARY outcome
Timeframe: Within 2 hours (h) prior to drug administration and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the treated set (TS) who provided at least one primary or secondary pharmacokinetic (PK) endpoint and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was included in the PKS even if he/she contributed with only 1 PK parameter value to the statistical assessment.
Maximum measured concentration of Iclepertin in plasma (Cmax) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Outcome measures
| Measure |
Iclepertin - Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment
n=8 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
|
145.06 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
139.86 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
177.03 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
150.83 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
146.15 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.08
|
152.00 nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 2 hours (h) prior to drug administration and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 h after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all participants in the treated set (TS) who provided at least one primary or secondary pharmacokinetic (PK) endpoint and that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A participant was included in the PKS even if he/she contributed with only 1 PK parameter value to the statistical assessment.
Area under the concentration-time curve of Iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric Least Squares Mean and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect, 'matched pair' as random effect. These quantities were then back-transformed to the original scale. Geometric Mean=Geometric Least Squares Mean and Standard Error= adjusted geometric standard error.
Outcome measures
| Measure |
Iclepertin - Mild Renal Impairment
n=8 Participants
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment
n=8 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Moderate Renal Impairment
n=8 Participants
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment
n=7 Participants
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
6664.69 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.15
|
5661.72 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.15
|
6531.93 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.16
|
6405.19 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.17
|
9606.90 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
6580.50 Hours * nanomoles/Liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
Adverse Events
Iclepertin - Mild Renal Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iclepertin - Moderate Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Iclepertin - Severe Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Iclepertin - Mild Renal Impairment
n=8 participants at risk
Participants with mild renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 60-89 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Mild Renal Impairment
n=8 participants at risk
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Moderate Renal Impairment
n=8 participants at risk
Participants with moderate renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 30-59 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Moderate Renal Impairment
n=7 participants at risk
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
Iclepertin - Severe Renal Impairment
n=8 participants at risk
Participants with severe renal impairment (estimated glomerular filtration rate (eGFR)) according to Chronic Kidney Disease Epidemiology Collaboration 15-29 milliliter(mL)/minute(min)/1.73 meter(m)²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Iclepertin - Normal Renal Function Matched to Severe Renal Impairment
n=7 participants at risk
Participants with normal renal function (eGFR ≥90 mL/min/1.73 m²) were administered orally one film-coated tablet of 10 milligram (mg) of Iclepertin with 240 mL of water after an overnight fast of at least 10 hours (h).
Participants with normal renal function were individually matched by age (± 10 years), gender, weight (± 15%), and race to the participants with renal impairment.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
12.5%
1/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
14.3%
1/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
|
Investigations
Lipase increased
|
12.5%
1/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/8 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
0.00%
0/7 • From the time of drug administration, plus 11 days (residual effect period (REP)), up to 11 days. All-cause mortality was recorded from the time of drug administration until the end of trial, up to 19 days.
Treated set (TS): Included all participants who were treated with at least 1 dose of the trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review Prior to any Submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI´s intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER