Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food (NCT NCT04789291)
NCT ID: NCT04789291
Last Updated: 2024-02-22
Results Overview
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
COMPLETED
PHASE1
13 participants
Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
2024-02-22
Participant Flow
This was an open-label, randomised, single centre trial using a two-way cross-over design. All subjects received a single oral dose of 30 mg BI 1595043 in film-coated tablet formulation following an overnight fast and after the ingestion of a standardised, high-calorie, high-fat breakfast. Administration sequence was randomly allocated with a wash-out period of at least 8 days between BI 1595043 doses.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1595043 Fasted (Reference (R)) / BI 1595043 Fed (Test (T))
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
BI 1595043 Fed (Test (T)) / BI 1595043 Fasted (Reference (R))
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Period 1
STARTED
|
7
|
6
|
|
Period 1
COMPLETED
|
7
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Wash-out
STARTED
|
7
|
6
|
|
Wash-out
COMPLETED
|
7
|
6
|
|
Wash-out
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
7
|
6
|
|
Period 2
COMPLETED
|
7
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food
Baseline characteristics by cohort
| Measure |
BI 1595043 Fasted (Reference (R)) / BI 1595043 Fed (Test (T))
n=7 Participants
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
BI 1595043 Fed (Test (T)) / BI 1595043 Fasted (Reference (R))
n=6 Participants
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
38.2 years
STANDARD_DEVIATION 5.8 • n=107 Participants
|
35.5 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 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
|
1 Participants
n=107 Participants
|
1 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
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 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: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was 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 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
BI 1595043 Under Fasted Condition (Reference (R))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
BI 1595043 Under Fed Condition (T (Test))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
NA hour*nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 4130.12. Standard Error is actually adjusted Geometric Standard Error = 1.06.
|
NA hour*nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 4244.02. Standard Error is actually adjusted Geometric Standard Error = 1.06.
|
PRIMARY outcome
Timeframe: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
BI 1595043 Under Fasted Condition (Reference (R))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
BI 1595043 Under Fed Condition (T (Test))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
|
NA nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 810.95. Standard Error is actually adjusted Geometric Standard Error = 1.06.
|
NA nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 630.96. Standard Error is actually adjusted Geometric Standard Error = 1.06.
|
SECONDARY outcome
Timeframe: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was 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 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Outcome measures
| Measure |
BI 1595043 Under Fasted Condition (Reference (R))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
BI 1595043 Under Fed Condition (T (Test))
n=13 Participants
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
NA hour*nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 4191.59. Standard Error is actually adjusted Geometric Standard Error = 1.07.
|
NA hour*nanomol/Liter
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 4327.59. Standard Error is actually adjusted Geometric Standard Error = 1.07.
|
Adverse Events
BI 1595043 Under Fed Condition (T (Test))
BI 1595043 Under Fasted Condition (Reference (R))
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1595043 Under Fed Condition (T (Test))
n=13 participants at risk
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
|
BI 1595043 Under Fasted Condition (Reference (R))
n=13 participants at risk
Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
7.7%
1/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
7.7%
1/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
7.7%
1/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
7.7%
1/13 • From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
|
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