Adults 18 to 55, 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 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)Primary· Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Group
Value
95% CI
T: BI 409306 + Rifampicin Pretreatment
NA
± NA
R: BI 409306
NA
± NA
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)Primary· Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.
Maximum measured concentration of BI 409306 in plasma (Cmax) is reported.
Group
Value
95% CI
T: BI 409306 + Rifampicin Pretreatment
NA
± NA
R: BI 409306
NA
± NA
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Secondary· Within 3 hours (h) before and 0.333h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 11h, 12h, 24h after drug administration.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Group
Value
95% CI
T: BI 409306 + Rifampicin Pretreatment
NA
± NA
R: BI 409306
NA
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration through the Residual effect period (REP) until end of trial; up to 14 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
R: BI 409306
Serious: 0/15 (0%)
Deaths: 0/15
Test Treatment, T: Rifampicin Pretreatment
Serious: 0/15 (0%)
Deaths: 0/15
Test Treatment, T: BI 409306 Subsequent to Rifampicin Pretreatment
The primary objective of this trial is to investigate the relative bioavailability of BI 409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306 tablets without prior administration of rifampicin (Reference, R) following oral administration in healthy male subjects.
The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments. The secondary objectives will be assessed by descriptive statistics.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT04602221 — A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ket
· Phase 1
· completed
NCT03934203 — This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)
· Phase 1
· completed
NCT03505151 — This Study in Healthy Men and Women Tests How the Body Takes up BI 409306
· Phase 1
· completed
NCT03351244 — This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Wel
· Phase 2
· terminated
NCT03230097 — This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndro
· Phase 2
· terminated
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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: 7 March 2024
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/NCT03151499.