Trial Outcomes & Findings for A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men (NCT NCT03802331)
NCT ID: NCT03802331
Last Updated: 2024-02-22
Results Overview
Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.
COMPLETED
PHASE1
12 participants
Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration
2024-02-22
Participant Flow
The trial was performed as a randomized, open-label, two-way crossover trial in healthy male subjects in order to compare the test treatment (T) with the reference treatment (R). The treatments were 2 single oral doses of BI 1323495, administered under fasted (R) and fed (T) conditions and separated by a washout period of at least 6 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 |
100 Milligram (mg) of BI1323495 Fasted-100 mg of BI1323495 Fed
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed condition) as a test treatment (T).
|
100 mg of BI1323495 Fed-100 mg of BI1323495 Fasted
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water 30 minutes after a high-fat, high-calorie meal as test treatment (T) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water after an overnight fast of at least 10 h as a reference treatment (R).
|
|---|---|---|
|
Treatment Period 1 (P1) + Washout
STARTED
|
6
|
6
|
|
Treatment Period 1 (P1) + Washout
COMPLETED
|
5
|
6
|
|
Treatment Period 1 (P1) + Washout
NOT COMPLETED
|
1
|
0
|
|
Treatment Period 2 (P2)
STARTED
|
5
|
6
|
|
Treatment Period 2 (P2)
COMPLETED
|
5
|
6
|
|
Treatment Period 2 (P2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
100 Milligram (mg) of BI1323495 Fasted-100 mg of BI1323495 Fed
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed condition) as a test treatment (T).
|
100 mg of BI1323495 Fed-100 mg of BI1323495 Fasted
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water 30 minutes after a high-fat, high-calorie meal as test treatment (T) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water after an overnight fast of at least 10 h as a reference treatment (R).
|
|---|---|---|
|
Treatment Period 1 (P1) + Washout
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Test How Food Influences the Amount of BI 1323495 in the Blood of Healthy Men
Baseline characteristics by cohort
| Measure |
100 Milligram (mg) of BI1323495 Fasted-100 mg of BI1323495 Fed
n=6 Participants
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed condition) as a test treatment (T).
|
100 mg of BI1323495 Fed-100 mg of BI1323495 Fasted
n=6 Participants
2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water 30 minutes after a high-fat, high-calorie meal as test treatment (T) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water after an overnight fast of at least 10 h as a reference treatment (R).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
32.3 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
32.3 Years
STANDARD_DEVIATION 6.2 • 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that 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 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.
Outcome measures
| Measure |
BI 1323495 Fed (T)
n=11 Participants
100 mg BI 1323495 as a single oral dose under fed conditions.
|
BI 1323495 Fasted (R)
n=12 Participants
100 mg BI 1323495 as a single oral dose under fasted conditions.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point
|
NA nanomol (nmol) * hours (h) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 1381.53 Standard Error is actually adjusted Geometric Standard Error = 1.34
|
NA nanomol (nmol) * hours (h) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 832.13 Standard Error is actually adjusted Geometric Standard Error = 1.34
|
PRIMARY outcome
Timeframe: Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administrationPopulation: PK parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that 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 1323495 in plasma (Cmax). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.
Outcome measures
| Measure |
BI 1323495 Fed (T)
n=11 Participants
100 mg BI 1323495 as a single oral dose under fed conditions.
|
BI 1323495 Fasted (R)
n=12 Participants
100 mg BI 1323495 as a single oral dose under fasted conditions.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1323495 in Plasma
|
NA nanomol (nmol) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 133.56 Standard Error is actually adjusted Geometric Standard Error = 1.34
|
NA nanomol (nmol) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 56.71 Standard Error is actually adjusted Geometric Standard Error = 1.34
|
SECONDARY outcome
Timeframe: Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administrationPopulation: PK parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that 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 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA.
Outcome measures
| Measure |
BI 1323495 Fed (T)
n=11 Participants
100 mg BI 1323495 as a single oral dose under fed conditions.
|
BI 1323495 Fasted (R)
n=12 Participants
100 mg BI 1323495 as a single oral dose under fasted conditions.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
|
NA nanomol (nmol) * hours (h) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 1471.84 Standard Error is actually adjusted Geometric Standard Error = 1.31
|
NA nanomol (nmol) * hours (h) / Litre (L)
Standard Error NA
Geometric Mean is actually adjusted Geometric Mean = 923.4 Standard Error is actually adjusted Geometric Standard Error = 1.31
|
Adverse Events
BI 1323495 Fed (T)
BI 1323495 Fasted (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1323495 Fed (T)
n=11 participants at risk
100 mg BI 1323495 as a single oral dose under fed conditions.
|
BI 1323495 Fasted (R)
n=12 participants at risk
100 mg BI 1323495 as a single oral dose under fasted conditions.
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/11 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
8.3%
1/12 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Otitis externa
|
9.1%
1/11 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/12 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/11 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
8.3%
1/12 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
8.3%
1/12 • From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place