This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated
CompletedPhase 1Results postedLast updated 4 June 2021
What this trial tests
Phase 1 trial testing BI 1467335 in Healthy in 48 participants. Completed in 16 December 2017.
Adults 20 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 Subjects With Drug-related Adverse EventsPrimary· From first day of trial medication intake until end of trial, up to 48 days.
Percentage of subjects with investigator-defined drug-related Adverse Events (AEs) is reported.
Group
Value
95% CI
Placebo (Japanese)
22.2
BI 1467335 3 mg Tablet (Japanese)
33.3
BI 1467335 6 mg Tablet (Japanese)
0.0
BI 1467335 10 mg Tablet (Japanese)
0.0
Placebo (Caucasian)
0.0
BI 1467335 10 mg Tablet (Caucasian)
11.1
AUC0-24Secondary· At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose (AUC0-24).
Group
Value
95% CI
BI 1467335 3 mg Tablet (Japanese)
0.898
± 69.4
BI 1467335 6 mg Tablet (Japanese)
2.05
± 31.4
BI 1467335 10 mg Tablet (Japanese)
14.7
± 66.9
BI 1467335 10 mg Tablet (Caucasian)
6.39
± 33.6
CmaxSecondary· At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
Group
Value
95% CI
BI 1467335 3 mg Tablet (Japanese)
0.791
± 60.3
BI 1467335 6 mg Tablet (Japanese)
1.71
± 53.9
BI 1467335 10 mg Tablet (Japanese)
8.27
± 64.5
BI 1467335 10 mg Tablet (Caucasian)
3.42
± 55.8
AUC0-24,28Secondary· At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of 28th dose (AUC0-24,28).
Group
Value
95% CI
BI 1467335 3 mg Tablet (Japanese)
21.4
± 51.1
BI 1467335 6 mg Tablet (Japanese)
117
± 33.7
BI 1467335 10 mg Tablet (Japanese)
1120
± 24.1
BI 1467335 10 mg Tablet (Caucasian)
721
± 86.2
Cmax,28Secondary· At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.
Maximum measured concentration of BI 1467335 in plasma following administration of 28th dose (Cmax,28).
Group
Value
95% CI
BI 1467335 3 mg Tablet (Japanese)
13.2
± 58.4
BI 1467335 6 mg Tablet (Japanese)
57.2
± 35.1
BI 1467335 10 mg Tablet (Japanese)
159
± 19.9
BI 1467335 10 mg Tablet (Caucasian)
124
± 41.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From first day of trial medication intake until end of trial, up to 48 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 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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: 4 June 2021
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/NCT03159455.