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 the BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)Primary· Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.
AUC0-tz, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 to the last quantifiable data point is presented.
Group
Value
95% CI
BI 730357 + Itraconazole (T)
43239.08
± NA
BI 730357 (R)
6657.49
± NA
Maximum Measured Concentration of the BI 730357 in Plasma (Cmax)Primary· Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.
Cmax, maximum measured concentration of the BI 730357 in plasma is presented here.
Group
Value
95% CI
BI 730357 + Itraconazole (T)
311.01
± NA
BI 730357 (R)
186.36
± NA
Area Under the Concentration-time Curve of the BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Secondary· Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.
AUC0-∞, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 extrapolated to infinity is presented here.
Group
Value
95% CI
BI 730357 + Itraconazole (T)
64934.55
± NA
BI 730357 (R)
6971.67
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: BI 730357: From first administration of BI 730357, up to 168 hours. Itraconazole: From first administration of itraconazole until second administration of BI 730357, up to 73 hours. BI 730357+ Itraconazole: From second administration of BI 730357 until 216 hours after the last administration of itraconazole, up to 18 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objective of this trial is to investigate the relative bioavailability of BI 730357 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04680676 — A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic A
· Phase 2
· withdrawn
NCT04679948 — A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazol
· Phase 1
· completed
NCT04590937 — A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and
· Phase 1
· completed
NCT04147260 — Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
· Phase 1
· completed
NCT03835481 — A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
· Phase 2
· terminated
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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: 12 July 2023
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/NCT03782987.