Adults 18 to 55, any sex, with Schizophrenia. 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.
Number of Participants With Drug-related Adverse EventsPrimary· From first drug administration until 30 days after last drug administration, up to 44 days.
Number of participants with drug-related adverse events.
Group
Value
95% CI
BI 409306 25mg
1
BI 409306 50mg
3
BI 409306 100mg
2
Placebo
3
Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Cmax)Secondary· 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration
Maximum measured concentration of BI 409306 in plasma after single dose (Cmax) is presented.
Group
Value
95% CI
BI 409306 25mg
138
± 91.9
BI 409306 50mg
431
± 73.3
BI 409306 100mg
998
± 106.0
Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Cmax,ss)Secondary· 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
Maximum measured concentration of BI 409306 in plasma at steady-state (Cmax,ss) is presented.
Group
Value
95% CI
BI 409306 25mg
99.2
± 86.8
BI 409306 50mg
631
± 90.9
BI 409306 100mg
1290
± 74.4
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma After Single Dose (Tmax)Secondary· 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
Time from dosing to maximum measured concentration of BI 409306 in plasma after single dose (tmax) is presented.
Group
Value
95% CI
BI 409306 25mg
0.625
0.33 – 1.50
BI 409306 50mg
0.625
0.33 – 2.00
BI 409306 100mg
0.750
0.33 – 2.00
Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma at Steady-state (Tmax,ss)Secondary· 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
Time from dosing to maximum measured concentration of BI 409306 in plasma at steady-state (tmax,ss) is presented.
Group
Value
95% CI
BI 409306 25mg
0.750
0.33 – 1.00
BI 409306 50mg
0.333
0.33 – 1.50
BI 409306 100mg
0.625
0.33 – 1.50
Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After a Single Dose (AUC0-infinity)Secondary· 2 hours (h) before first drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h and 14h after first drug administration.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after a single dose (AUC0-infinity) is presented.
Group
Value
95% CI
BI 409306 25mg
217
± 107.0
BI 409306 50mg
770
± 98.4
BI 409306 100mg
2020
± 108.0
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)Secondary· 2 hours (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 48h and 72h after drug administration on day 14.
Area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss) is presented.
Group
Value
95% CI
BI 409306 25mg
147
± 112.0
BI 409306 50mg
969
± 104.0
BI 409306 100mg
2280
± 86.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study medication until 30 days after the last dose of study medication, up to 44 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 409306 in schizophrenic patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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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: 25 April 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/NCT01892384.