Trial Outcomes & Findings for Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers (NCT NCT02222168)
NCT ID: NCT02222168
Last Updated: 2024-07-31
Results Overview
Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C
COMPLETED
PHASE1
18 participants
Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h
2024-07-31
Participant Flow
Eighteen healthy subjects were entered and treated and completed the planned observation time. All 18 subjects received study medication (open-label) under fasted (Treatment A) and fed (Treatment B) conditions in a two-way crossover fashion followed by a fixed sequence administered at bed time (Treatment C).
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
BI 409306 Fasted/Fed/Bed Time
Single oral dose of 25 milligram (mg) BI 409306 film-coated tablet, with 240 millilitre (ml) water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations.
|
BI 409306 Fed/Fasted/Bed Time
Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations.
|
|---|---|---|
|
Period 1 (Fasted or Fed)
STARTED
|
9
|
9
|
|
Period 1 (Fasted or Fed)
COMPLETED
|
9
|
9
|
|
Period 1 (Fasted or Fed)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (Fasted or Fed)
STARTED
|
9
|
9
|
|
Period 2 (Fasted or Fed)
COMPLETED
|
9
|
9
|
|
Period 2 (Fasted or Fed)
NOT COMPLETED
|
0
|
0
|
|
Period 3 (Bed-time)
STARTED
|
9
|
9
|
|
Period 3 (Bed-time)
COMPLETED
|
9
|
9
|
|
Period 3 (Bed-time)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BI 409306 Fasted/Fed/Bed Time
n=9 Participants
Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations.
|
BI 409306 Fed/Fasted/Bed Time
n=9 Participants
Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 5.4 • n=39 Participants
|
44.3 years
STANDARD_DEVIATION 9.1 • n=41 Participants
|
37.3 years
STANDARD_DEVIATION 10.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00hPopulation: The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.
Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C
Outcome measures
| Measure |
BI 409306 Fasted
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.
|
BI 409306 Fed
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.
|
BI 409306 at Bed-time
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time
|
|---|---|---|---|
|
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
|
183 Nanomole per litre
Geometric Coefficient of Variation 118
|
175 Nanomole per litre
Geometric Coefficient of Variation 69.5
|
150 Nanomole per litre
Geometric Coefficient of Variation 119
|
PRIMARY outcome
Timeframe: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00hPopulation: The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.
AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C
Outcome measures
| Measure |
BI 409306 Fasted
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.
|
BI 409306 Fed
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.
|
BI 409306 at Bed-time
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz)
|
273 Hour times nanomole per litre
Geometric Coefficient of Variation 118
|
293 Hour times nanomole per litre
Geometric Coefficient of Variation 96.4
|
259 Hour times nanomole per litre
Geometric Coefficient of Variation 117
|
SECONDARY outcome
Timeframe: Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00hPopulation: The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS.
AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C.
Outcome measures
| Measure |
BI 409306 Fasted
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.
|
BI 409306 Fed
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.
|
BI 409306 at Bed-time
n=18 Participants
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
|
273 Hour times nanomole per litre
Geometric Coefficient of Variation 118
|
293 Hour times nanomole per litre
Geometric Coefficient of Variation 96.3
|
259 Hour times nanomole per litre
Geometric Coefficient of Variation 116
|
Adverse Events
BI 409306 Fasted
BI 409306 Fed
BI 409306 at Bed-time
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 409306 Fasted
n=18 participants at risk
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition.
|
BI 409306 Fed
n=18 participants at risk
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition.
|
BI 409306 at Bed-time
n=18 participants at risk
Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
|
General disorders
Feeling hot
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
11.1%
2/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
0.00%
0/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
5.6%
1/18 • From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
|
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