PRA Health Sciences Onderzoekscentrum Martini
Groningen, 9728 NZ, Netherlands
NCT Number: NCT03664011
The main objectives of the study are as follows:
* To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as 14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base (BS) (C-14) in healthy male subjects * To provide plasma, urine, and faecal samples for metabolite profiling and structural identification
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Notify Me18 year–65 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
Oral Solution
Time frame: Within 18 hours (h) predose, 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, 312-336 h after dosing on Day 1, continued in 24 h intervals, every 7 days from Day 21 until Day 50.
feurine, fractions of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
Time frame: Within 48 hours (h) predose, 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 and 312-336 h after dosing on Day 1 and continued in 24 h intervals, every 7 days up to Day 50.
fefaeces, 0-tz, fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants.
Time frame: Within 3:00 Hours: minutes (h:m) pre-dose, 0:30, 1:00, 1:30, 2:00, 4:00, 8:00, 12:00, 24:00, 48:00, 72:00, 120:00, 168:00, 216:00, 264:00, 312:00, 485:00, 653:00 and 821:00 after drug administration.
Cmax, maximum measured concentration of 14C-BI 730357-equivalent (EQ) and BI 730357 in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
Time frame: Within 3:00 Hours: minutes (h:m) pre-dose, 0:30, 1:00, 1:30, 2:00, 4:00, 8:00, 12:00, 24:00, 48:00, 72:00, 120:00, 168:00, 216:00, 264:00, 312:00, 485:00, 653:00 and 821:00 after drug administration.
AUC0-tz, area under the concentration-time curve of 14C-BI 730357-equivalent (EQ) and BI 730357 over the time interval from 0 to the last quantifiable time point in plasma after a single oral dose of 50 mg BI 730357 BS (C-14) is presented. Plasma concentrations of (C-14) BI 730357-radioactivity are expressed as 14C-BI 730357-EQ.
Boehringer Ingelheim
Industry
A Phase I, Open-label, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of BI 730357 BS (C-14) Administered as Oral Solution in Healthy Male Volunteers
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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