Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body (NCT NCT05707403)
NCT ID: NCT05707403
Last Updated: 2025-11-28
Results Overview
Dose normalized AUC0-inf of \[14C\]-BI 1015550 after intravenous (i.v.) administration and AUC0-inf of BI 1015550 after oral (p.o.) administration are reported. The analysis was performed only on the pharmacologically active R-enantiomer.
COMPLETED
PHASE1
8 participants
Between waking up and still prior to drug intake and 0.5*, 0.75*, 1*, 1.5*, 1.58±, 1.67±, 1.75, 2, 2.5±, 3, 4, 5±, 6, 7±, 8, 12, 16, 24, 36, 48, 72, 120, 168, 216± hours after intake of oral BI 1015550 tablet, *for T treatment, ±only for R treatment.
2025-11-28
Participant Flow
A non-randomised, open-label, single period, single arm trial to determine the absolute oral bioavailability of BI 1015550 in healthy male subjects.
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 |
18 mg BI 1015550 / 100 μg BI 1015550 (C-14)
One film-coated tablet of 18 milligram (mg) BI 1015550 was administered as single oral dose with 240 milliliter of water after an overnight fast of at least 10 hours on Day 1 as test treatment (T). 100 microgram (μg) BI 1015550 (C-14) solution (consisting of 90 μg unlabelled BI 1015550 mixed with 10 μg labelled \[14C\]-BI 1015550 in 10 mL intravenous solution with a final concentration of 10 μg BI 1015550 (C-14)/mL) was administered as single intravenous infusion over 15 minutes on Day 1 as reference treatment (R). The radioactive dose per infusion was \~40 kilobecquerel (kBq).
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|---|---|
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Overall Study
STARTED
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8
|
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Overall Study
COMPLETED
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8
|
|
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 Test How BI 1015550 is Taken up and Handled by the Body
Baseline characteristics by cohort
| Measure |
18 mg BI 1015550 / 100 μg BI 1015550 (C-14)
n=8 Participants
One film-coated tablet of 18 milligram (mg) BI 1015550 was administered as single oral dose with 240 milliliter of water after an overnight fast of at least 10 hours on Day 1 as test treatment (T). 100 microgram (μg) BI 1015550 (C-14) solution (consisting of 90 μg unlabelled BI 1015550 mixed with 10 μg labelled \[14C\]-BI 1015550 in 10 mL intravenous solution with a final concentration of 10 μg BI 1015550 (C-14)/mL) was administered as single intravenous infusion over 15 minutes on Day 1 as reference treatment (R). The radioactive dose per infusion was \~40 kilobecquerel (kBq).
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|---|---|
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Age, Continuous
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28.9 Years
STANDARD_DEVIATION 13.9 • n=30 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=30 Participants
|
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Sex: Female, Male
Male
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8 Participants
n=30 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=30 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=30 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=30 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=30 Participants
|
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Race (NIH/OMB)
Asian
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1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=30 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=30 Participants
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Race (NIH/OMB)
White
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6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Between waking up and still prior to drug intake and 0.5*, 0.75*, 1*, 1.5*, 1.58±, 1.67±, 1.75, 2, 2.5±, 3, 4, 5±, 6, 7±, 8, 12, 16, 24, 36, 48, 72, 120, 168, 216± hours after intake of oral BI 1015550 tablet, *for T treatment, ±only for R treatment.Population: Pharmacokinetic (PK) set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to non-evaluability.
Dose normalized AUC0-inf of \[14C\]-BI 1015550 after intravenous (i.v.) administration and AUC0-inf of BI 1015550 after oral (p.o.) administration are reported. The analysis was performed only on the pharmacologically active R-enantiomer.
Outcome measures
| Measure |
R-BI 1015550 18 mg tablet (T)
n=8 Participants
Unlabelled pharmacologically active R-enantiomer of one film-coated tablet of 18 mg BI 1015550, as test treatment (T).
|
14C-R-BI 1015550 10 μg i.v. (R)
n=8 Participants
Intravenous microtracer infusion of 100 ug BI 1015550 (C-14) solution containing 10 ug 14C radiolabelled pharmacologically active R-enantiomer of BI 1015550, as reference treatment (R).
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|---|---|---|
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Dose Normalized Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
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118.27 Hours*millimole/liter/kilogram
Standard Error 1.07
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161.69 Hours*millimole/liter/kilogram
Standard Error 1.07
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SECONDARY outcome
Timeframe: Between waking up and still prior to drug intake and 0.5*, 0.75*, 1*, 1.5*, 1.58±, 1.67±, 1.75, 2, 2.5±, 3, 4, 5±, 6, 7±, 8, 12, 16, 24, 36, 48, 72, 120, 168, 216± hours after intake of oral BI 1015550 tablet, *for T treatment, ±only for R treatment.Population: Pharmacokinetic (PK) set (PKS): All subjects in the treated set (TS) who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to non-evaluability.
Dose normalized Cmax of BI 1015550 after oral administration and Cmax of \[14C\]-BI 1015550 after intravenous administration is reported. The analysis was performed only on the pharmacologically active R-enantiomer.
Outcome measures
| Measure |
R-BI 1015550 18 mg tablet (T)
n=8 Participants
Unlabelled pharmacologically active R-enantiomer of one film-coated tablet of 18 mg BI 1015550, as test treatment (T).
|
14C-R-BI 1015550 10 μg i.v. (R)
n=8 Participants
Intravenous microtracer infusion of 100 ug BI 1015550 (C-14) solution containing 10 ug 14C radiolabelled pharmacologically active R-enantiomer of BI 1015550, as reference treatment (R).
|
|---|---|---|
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Dose Normalized Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
|
24.53 Picomole/Liter/microgram
Geometric Coefficient of Variation 1.13
|
73.05 Picomole/Liter/microgram
Geometric Coefficient of Variation 1.13
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Adverse Events
18 mg BI 1015550 / 100 μg BI 1015550 (C-14)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
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