ICON
Groningen, 9728 NZ, Netherlands
NCT Number: NCT05833035
The main objective of this trial is to
* Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) * Provide plasma and urine samples for pharmacokinetic investigations * Provide plasma, urine, and faeces samples for metabolic profiling and structural identification of metabolites
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BI 1291583 mixed with radioactive carbon labelled [C-14] BI 1291583
Time frame: Urine sampling intervals: Within 14 hours (h) prior and 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336h after intake of BI 1291583 (C14). Continues in description.
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 (feurine, 0-tz) is reported.
Timeframe: After 336h, 24h interval urine sample collection was planned every 7 days starting on Day 21 until Day 43.
Time frame: All stools were collected prior and up to 336 hours (h) (sampling intervals 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216 -240, 240-264, 264-288, 288-312, 312-336 h) after intake of BI 1291583 (C14). Continues in description.
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 (fefaeces, 0-tz) is reported.
Timeframe: After 336h, 24h interval stools sample collection was planned every 7 days starting on Day 21 until Day 43.
Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).
Area under the concentration-time curve of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, [14C]-BI 1291583-EQ) is reported.
Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).
Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583) is reported.
Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).
Maximum measured concentration of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma (Cmax, [14C]-BI 1291583-EQ) is reported.
Time frame: Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14).
Maximum measured concentration of BI 1291583 in plasma (Cmax, BI 1291583) is reported.
Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).
Area under the concentration-time curve of BI 1291583 metabolites in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583 metabolites). AUC0-tz of the following BI 1291583 metabolites is reported:
BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869.
Time frame: Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14).
Maximum measured concentration of BI 1291583 metabolites in plasma (Cmax, BI 1291583 metabolites). Cmax of the following metabolites is reported:
BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869.
Boehringer Ingelheim
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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