Trial Outcomes & Findings for A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body (NCT NCT03302091)
NCT ID: NCT03302091
Last Updated: 2021-06-04
Results Overview
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 AUC 0-24. Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
COMPLETED
PHASE1
20 participants
Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
2021-06-04
Participant Flow
This was open-label, multiple-dose and matched-group design. 20 participants entered (ten in each of the two groups). Participants with moderate renal impairment were assigned to the moderate group and individually matched participants with normal renal function were assigned to the normal group.
All participants were screened for eligibility to participate in the trial. Participants attended a specialist site which would then ensure that they (the participants) met all strictly implemented inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
BI 1467335 Normal (R)
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body
Baseline characteristics by cohort
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 Years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
68.7 Years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
68.1 Years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
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 AUC 0-24. Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=9 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=9 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
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 nanomole*hour/Liter (nmol*h/L)
Standard Error 1.31
|
7.88 nanomole*hour/Liter (nmol*h/L)
Standard Error 1.31
|
PRIMARY outcome
Timeframe: Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax). Standard Error presented is actually geometric Standard Error.
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax)
|
3.03 nanomole/Liter (nmol/L)
Standard Error 1.24
|
6.01 nanomole/Liter (nmol/L)
Standard Error 1.24
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
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 nanomole*hours/Liter (nmol*h/L)
Standard Error 1.23
|
1566.88 nanomole*hours/Liter (nmol*h/L)
Standard Error 1.23
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28)
|
100.57 nanomole/Liter (nmol/L)
Standard Error 1.13
|
141.20 nanomole/Liter (nmol/L)
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
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 nanomole*hour/Liter (nmol*h/L)
Standard Error 1.34
|
532.06 nanomole*hour/Liter (nmol*h/L)
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.Population: PK statistical analysis set (PKS-stat) included all subjects from PK set who built a subject pair of renally impaired subject and her/his matching healthy volunteer control and provided at least one primary or secondary PK parameter and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14). Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
BI 1467335 Normal (R)
n=10 Participants
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 Participants
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14)
|
73.41 nanomole/Liter (nmol/L)
Standard Error 1.16
|
94.28 nanomole/Liter (nmol/L)
Standard Error 1.16
|
Adverse Events
BI 1467335 Normal (R)
BI 1467335 Moderate (T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1467335 Normal (R)
n=10 participants at risk
Participants with normal renal function were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
BI 1467335 Moderate (T)
n=10 participants at risk
Participants with moderate renal impairment were administered 10 milligram (mg) (5 mg X2) BI 1467335 film coated tablet orally with 240 milliliter (mL) water after an overnight fast of at least 10 hour (h) once daily over 28 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
10.0%
1/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
20.0%
2/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
0.00%
0/10 • From first day of study drug administration until End of trial (EOT), up to 41 days.
The treated set (TS) included all subjects who were documented to have taken at least one dose of trial medication. This is the full analysis set population in the sense of ICH-E9.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
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