Adults 18 to 50, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)Primary· Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.
Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm).
Time frame for treatment T1:
Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug.
Time frame for treatment T2 and T3:
Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug.
Time frame for treatment R:
Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10
Group
Value
95% CI
BI 1265162 as Infusion (R)
44.63
± NA
BI 1265162 as Oral Solution (T1)
0.22
± NA
BI 1265162 for Inhalation With Activated Charcoal (T2)
17.97
± NA
BI 1265162 for Inhalation Without Activated Charcoal (T3)
17.96
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BI 1265162 as Infusion (R)
Serious: 0/12 (0%)
Deaths: 0/12
BI 1265162 as Oral Solution (T1)
Serious: 1/12 (8%)
Deaths: 0/12
BI 1265162 for Inhalation With Activated Charcoal (T2)
Serious: 0/11 (0%)
Deaths: 0/11
BI 1265162 for Inhalation Without Activated Charcoal (T3)
The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 6 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03907280.