Adults 18 to 45, 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.
Percentage of Participants With Drug-related Adverse EventsPrimary· From drug administration until end of trial, up to 15 days.
Percentage of participants with drug-related adverse events.
Group
Value
95% CI
Placebo Matching BI 1323495
6.7
BI 1323495 Dose Group 1
50.0
BI 1323495 Dose Group 2
33.3
BI 1323495 Dose Group 3
0.0
BI 1323495 Dose Group 4
16.7
BI 1323495 Dose Group 5
0.0
BI 1323495 Dose Group 6
16.7
BI 1323495 Dose Group 7
50.0
BI 1323495 Dose Group 8
16.7
Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)Secondary· 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.
Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) after single oral administration of BI 1323495.
Group
Value
95% CI
BI 1323495 Dose Group 1
143
± 102.0
BI 1323495 Dose Group 2
883
± 118.0
BI 1323495 Dose Group 3
824
± 77.7
BI 1323495 Dose Group 4
2360
± 73.5
BI 1323495 Dose Group 5
3710
± 69.4
BI 1323495 Dose Group 6
3120
± 140.0
BI 1323495 Dose Group 7
1780
± 102.0
BI 1323495 Dose Group 8
3820
± 71.9
Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)Secondary· 1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.
Maximum measured concentration of BI 1323495 in plasma (Cmax) after single oral administration of BI 1323495.
Group
Value
95% CI
BI 1323495 Dose Group 1
10.5
± 66.3
BI 1323495 Dose Group 2
59.4
± 147.0
BI 1323495 Dose Group 3
145.0
± 74.8
BI 1323495 Dose Group 4
229.0
± 127.0
BI 1323495 Dose Group 5
179.0
± 152.0
BI 1323495 Dose Group 6
136.0
± 74.2
BI 1323495 Dose Group 7
195.0
± 90.8
BI 1323495 Dose Group 8
195.0
± 90.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From drug administration until end of trial, up to 15 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the assessment of the PK/PD relationship.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT04656275 — A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated
· Phase 1
· terminated
NCT04619251 — A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences
· Phase 1
· completed
NCT04107805 — A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated
· Phase 1
· completed
NCT04011241 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood
· Phase 1
· completed
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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: 22 February 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/NCT03588390.