A phase I, open-label, single dose, mass balance trial to investigate metabolism and pharmacokinetics of BI 1291583(C-14) administered as oral solution in healthy male subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502264-20-00

Acronym

1397-0016

Enrollment

Registered

2023-04-14

Start date

2023-04-26

Completion date

2023-07-05

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

feurine, 0-tz (fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point), fefaeces, 0-tz (fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)

Detailed description

Cmax (maximum measured concentration of the analyte), AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)

Interventions

None listed

Eligibility

Sex/Gender

Male

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
feurine, 0-tz (fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point), fefaeces, 0-tz (fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)	—

Secondary

Measure	Time frame
Cmax (maximum measured concentration of the analyte), AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)	—

Countries

Netherlands

Outcome results