The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
BI 764198 (C-14) (approach 1)
BI 764198 (C-14) (approach 2)
ICON
Groningen, Netherlands
Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces.
Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria.
Time frame: Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section.
AUC0-tz, Area Under the Concentration-time Curve of [14C]-BI 764198-EQ Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of \[14C\]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form.
Time frame: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.
AUC0-tz, Area Under the Concentration-time Curve of BI 764198 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points.
Time frame: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of \[14C\]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. This standardization ensures that the data can be accurately compared to the unlabeled BI 764198.
Time frame: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.
Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418.
For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if \[14C\]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points.
Time frame: Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.