Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood (NCT NCT03871595)
NCT ID: NCT03871595
Last Updated: 2023-08-14
Results Overview
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.
COMPLETED
PHASE1
14 participants
Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.
2023-08-14
Participant Flow
A randomised, open-label, two-sequence crossover, single-dose, two-period trial in healthy male subjects to compare the test treatment (T) to the reference treatment (R). The treatments were 2 single oral doses of BI 894416 , administered under fasted (R) and fed (T) conditions and separated by a wash-out period of at least 5 days.
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 |
30 mg of BI 894416 Fasted - 30 mg of BI 894416 Fed
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R) followed by a wash-out period of at least 5 days followed by 3 tablets with 10 mg of BI 894416 (total: 30 mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
30 mg of BI 894416 Fed - 30 mg of BI 894416 Fasted
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T) followed by a wash-out period of at least 5 days followed by 3 tablets with 10 mg of BI 894416 (total: 30 mg) administered as a single oral dose with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
|---|---|---|
|
Treatment Period 1 (P1) + Wash-out
STARTED
|
7
|
7
|
|
Treatment Period 1 (P1) + Wash-out
COMPLETED
|
7
|
7
|
|
Treatment Period 1 (P1) + Wash-out
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (P2)
STARTED
|
7
|
7
|
|
Treatment Period 2 (P2)
COMPLETED
|
7
|
7
|
|
Treatment Period 2 (P2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Baseline characteristics by cohort
| Measure |
30 mg of BI 894416 Fasted - 30 mg of BI 894416 Fed
n=7 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R) followed by a wash-out period of at least 5 days followed by 3 tablets with 10 mg of BI 894416 (total: 30 mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
30 mg of BI 894416 Fed - 30 mg of BI 894416 Fasted
n=7 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T) followed by a wash-out period of at least 5 days followed by 3 tablets with 10 mg of BI 894416 (total: 30 mg) administered as a single oral dose with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.Population: The pharmacokinetic set included all subjects who received at least one dose of trial medication and provided at least one PK endpoint that was defined as primary and that was not excluded due to relevant protocol deviations or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.
Outcome measures
| Measure |
BI 894416 30 mg Fed (T)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
BI 894416 30 mg Fast (R)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
4436.69 nanomole (nmol) * hour (h) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.05.
|
4458.63 nanomole (nmol) * hour (h) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.05.
|
PRIMARY outcome
Timeframe: Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.Population: The pharmacokinetic set included all subjects who received at least one dose of trial medication and provided at least one PK endpoint that was defined as primary and that was not excluded due to relevant protocol deviations or due to PK non-evaluability.
Maximum measured concentration of BI 894416 in plasma (Cmax). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.
Outcome measures
| Measure |
BI 894416 30 mg Fed (T)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
BI 894416 30 mg Fast (R)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
|---|---|---|
|
Maximum Measured Concentration of BI 894416 in Plasma (Cmax)
|
492.90 nanomole (nmol) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.06.
|
703.05 nanomole (nmol) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.06.
|
SECONDARY outcome
Timeframe: Within 3 hours before and then 15 minutes (min), 30 min, 45 min, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34 and 48 hours after drug administration.Population: The pharmacokinetic set included all subjects who received at least one dose of trial medication and provided at least one PK endpoint that was defined as primary and that was not excluded due to relevant protocol deviations or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞ ). Time points of pharmacokinetic (PK) blood samples are given as planned time relative to start of drug administration.
Outcome measures
| Measure |
BI 894416 30 mg Fed (T)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
BI 894416 30 mg Fast (R)
n=14 Participants
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
|
4463.26 nanomole (nmol) * hour (h) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.05
|
4472.94 nanomole (nmol) * hour (h) / liter (L)
Standard Error NA
Standard Error is Geometric standard error (gSE) = 1.05
|
Adverse Events
BI 894416 30 mg Fed (T)
BI 894416 30 mg Fast (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 894416 30 mg Fed (T)
n=14 participants at risk
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T).
|
BI 894416 30 mg Fast (R)
n=14 participants at risk
3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
7.1%
1/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
7.1%
1/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
0.00%
0/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who received at least one dose of trial medication.
|
7.1%
1/14 • From drug administration until the next drug administration or end of trial, up to 15 days.
The treated set included all subjects who 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
- Publication restrictions are in place