Labcorp Clinical Research Unit
Leeds, LS2 9LH, United Kingdom
NCT Number: NCT04962724
The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of [14C]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of [14C]-xevinapant as well as identify metabolites. In addition, the study will allow to determine absolute bioavailability of xevinapant and understand its intravenous pharmacokinetics.
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Notify Me18 year–65 year
Male
Interventional
Phase 1
Leeds, LS2 9LH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
[14C]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) [3.7 megabecquerel (MBq)] in fasted conditions.
100 μg [14C]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi [7.4 kilobecquerel (kBq)].
Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 8
Time frame: Up to Day 5
Absolute Bioavailability (F) = (AUC0-infinity [oral]/ dose [oral]) /(AUC0-infinity [IV]/ dose [IV])
Time frame: Up to Day 8
Time frame: Up to Day 8
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Time frame: Up to Day 29
Debiopharm International SA
Industry
A Phase 1, Open-label, 2-part, Single-dose Study of the Absorption, Metabolism, and Excretion of Oral [14C]-Xevinapant, and Absolute Oral Bioavailability of Xevinapant 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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