ICON
Groningen, 9728 NZ, Netherlands
NCT Number: NCT05707403
This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550. These data are considered necessary to further support the understanding of the pharmacokinetics of BI 1015550.
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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
Treatment T
Other names: Nerandomilast, JASCAYD®
Treatment R
Other names: Nerandomilast, JASCAYD®
Time frame: Between waking up and still prior to drug intake and 0.5*, 0.75*, 1*, 1.5*, 1.58±, 1.67±, 1.75, 2, 2.5±, 3, 4, 5±, 6, 7±, 8, 12, 16, 24, 36, 48, 72, 120, 168, 216± hours after intake of oral BI 1015550 tablet, *for T treatment, ±only for R treatment.
Dose normalized AUC0-inf of [14C]-BI 1015550 after intravenous (i.v.) administration and AUC0-inf of BI 1015550 after oral (p.o.) administration are reported. The analysis was performed only on the pharmacologically active R-enantiomer.
Time frame: Between waking up and still prior to drug intake and 0.5*, 0.75*, 1*, 1.5*, 1.58±, 1.67±, 1.75, 2, 2.5±, 3, 4, 5±, 6, 7±, 8, 12, 16, 24, 36, 48, 72, 120, 168, 216± hours after intake of oral BI 1015550 tablet, *for T treatment, ±only for R treatment.
Dose normalized Cmax of BI 1015550 after oral administration and Cmax of [14C]-BI 1015550 after intravenous administration is reported. The analysis was performed only on the pharmacologically active R-enantiomer.
Boehringer Ingelheim
Industry
Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1015550 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1015550 in Healthy Male Volunteers
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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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