Trial Outcomes & Findings for A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body (NCT NCT03654170)
NCT ID: NCT03654170
Last Updated: 2026-03-27
Results Overview
feurine, 0-t2, fraction of \[14C\]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total \[14C\]-radioactivity in urine.
COMPLETED
PHASE1
6 participants
PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.
2026-03-27
Participant Flow
This trial was performed as a non-randomised, open-label, single period, single arm trial in healthy male participants.
All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 425809 XX (C-14)
Participants were administered single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled \[14C\] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent, with 240 mL of water after an overnight fast of at least 10 hours (h).
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body
Baseline characteristics by cohort
| Measure |
BI 425809 XX (C-14)
n=6 Participants
Participants were administered single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled \[14C\] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent, with 240 mL of water after an overnight fast of at least 10 hours (h).
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Age, Continuous
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45.7 Years
STANDARD_DEVIATION 17.7 • n=56 Participants
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Sex: Female, Male
Female
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0 Participants
n=56 Participants
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Sex: Female, Male
Male
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6 Participants
n=56 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=56 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=56 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=56 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=56 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=56 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=56 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=56 Participants
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Race (NIH/OMB)
White
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5 Participants
n=56 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=56 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=56 Participants
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PRIMARY outcome
Timeframe: PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints.
feurine, 0-t2, fraction of \[14C\]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total \[14C\]-radioactivity in urine.
Outcome measures
| Measure |
[14C] BI 425809
n=6 Participants
Participants were administered a radioactive dose of 3.7 MBq labelled \[14C\] BI 425809 XX mixed with 25 mg unlabeled BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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BI 425809
Participants were administered 25 mg unlabeled BI 425809 XX mixed with a radioactive dose of 3.7 MBq Carbon 14 labelled \[14C\] BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-t2)
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48.1 Percentage of dose excreted (%)
Geometric Coefficient of Variation 9.6
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—
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PRIMARY outcome
Timeframe: PKfaeces samples were collected within 2 hours predose and within 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints.
fefaeces, 0-t2, fraction of \[14C\]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total \[14C\]-radioactivity in faeces.
Outcome measures
| Measure |
[14C] BI 425809
n=6 Participants
Participants were administered a radioactive dose of 3.7 MBq labelled \[14C\] BI 425809 XX mixed with 25 mg unlabeled BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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BI 425809
Participants were administered 25 mg unlabeled BI 425809 XX mixed with a radioactive dose of 3.7 MBq Carbon 14 labelled \[14C\] BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-t2)
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48.3 Percentage of dose excreted (%)
Geometric Coefficient of Variation 14.3
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—
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SECONDARY outcome
Timeframe: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints.
Maximum measured concentration of the \[14C\]-radioactivity and BI 425809 (Cmax).
Outcome measures
| Measure |
[14C] BI 425809
n=6 Participants
Participants were administered a radioactive dose of 3.7 MBq labelled \[14C\] BI 425809 XX mixed with 25 mg unlabeled BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
|
BI 425809
n=6 Participants
Participants were administered 25 mg unlabeled BI 425809 XX mixed with a radioactive dose of 3.7 MBq Carbon 14 labelled \[14C\] BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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Maximum Measured Concentration of the [14C]-Radioactivity and BI 425809 (Cmax)
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503 nanomole (nmol) / Liter (L)
Geometric Coefficient of Variation 15.6
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383 nanomole (nmol) / Liter (L)
Geometric Coefficient of Variation 14.2
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SECONDARY outcome
Timeframe: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of the \[14C\]-radioactivity and BI 425809 over the time interval from 0 to the last quantifiable time point (AUC0-tz). For \[14C\]-radioactivity the latest tz was 653 h whereas for BI 425809 the latest tz was 336 h.
Outcome measures
| Measure |
[14C] BI 425809
n=6 Participants
Participants were administered a radioactive dose of 3.7 MBq labelled \[14C\] BI 425809 XX mixed with 25 mg unlabeled BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
|
BI 425809
n=6 Participants
Participants were administered 25 mg unlabeled BI 425809 XX mixed with a radioactive dose of 3.7 MBq Carbon 14 labelled \[14C\] BI 425809 XX to form an oral solution of 2 mg/mL concentration with 240 mL of water after an overnight fast of at least 10 hours (h).
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Area Under the Concentration-time Curve of the [14C]-Radioactivity and BI 425809 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
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59300 nanomole*hours/Liter
Geometric Coefficient of Variation 16.4
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12000 nanomole*hours/Liter
Geometric Coefficient of Variation 33.4
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Adverse Events
BI 425809 XX (C-14)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 425809 XX (C-14)
n=6 participants at risk
Participants were administered single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled \[14C\] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent, with 240 mL of water after an overnight fast of at least 10 hours (h).
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Nervous system disorders
Headache
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50.0%
3/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Nervous system disorders
Dizziness
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Gastrointestinal disorders
Abdominal discomfort
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Gastrointestinal disorders
Diarrhoea
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Gastrointestinal disorders
Faeces discoloured
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Gastrointestinal disorders
Flatulence
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Gastrointestinal disorders
Frequent bowel movements
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Infections and infestations
Conjunctivitis
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Infections and infestations
Rhinitis
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Musculoskeletal and connective tissue disorders
Myalgia
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Psychiatric disorders
Insomnia
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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Renal and urinary disorders
Pollakiuria
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16.7%
1/6 • All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.
Treated Set (TS): This subject set included all subjects who received at least 1 dose of trial medication.
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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