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.
Percentage of Subjects With Drug-related Adverse EventsPrimary· From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Percentage of subjects with drug-related adverse events.
Group
Value
95% CI
Placebo
6.3
4 mg BI 764122
0.0
12 mg BI 764122
16.7
25 mg BI 764122
0.0
50 mg BI 764122
0.0
100 mg BI 764122
0.0
200 mg BI 764122
0.0
300 mg BI 764122
0.0
400 mg BI 764122
0.0
50 mg BI 764122 Fasted
8.3
50 mg BI 764122 Fed
8.3
Area Under the Concentration-time Curve of BI 764122 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)Secondary· Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.
Area under the concentration-time curve of BI 764122 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Group
Value
95% CI
4 mg BI 764122
534
± 19.0
12 mg BI 764122
1530
± 33.3
25 mg BI 764122
2850
± 15.1
50 mg BI 764122
5260
± 23.5
100 mg BI 764122
9810
± 14.1
200 mg BI 764122
19400
± 14.4
300 mg BI 764122
29600
± 12.2
400 mg BI 764122
45700
± 17.4
50 mg BI 764122 Fasted
6000
± 20.5
50 mg BI 764122 Fed
5810
± 20.5
Maximum Measured Concentration of BI 764122 in Plasma (Cmax)Secondary· Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.
Maximum measured concentration of BI 764122 in plasma (Cmax).
Group
Value
95% CI
4 mg BI 764122
154
± 22.9
12 mg BI 764122
565
± 16.7
25 mg BI 764122
1280
± 35.3
50 mg BI 764122
2550
± 24.9
100 mg BI 764122
4410
± 45.6
200 mg BI 764122
8090
± 19.3
300 mg BI 764122
13300
± 48.4
400 mg BI 764122
18600
± 21.1
50 mg BI 764122 Fasted
2610
± 46.3
50 mg BI 764122 Fed
1510
± 35.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From drug administration until 11 days thereafter for both single rising doses and food effect parts..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.
The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.
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: 1 May 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/NCT03794323.