Quotient Sciences
Ruddington, Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT04952467
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
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Notify Me30 year–65 year
Male
Interventional
Phase 1
Ruddington, Nottingham, NG11 6JS, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
Time frame: From Screening up to Day 57 post-dose
Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
Chemical structure of each metabolite classified as >10% (by AUC) of total radioactivity in plasma and >10% dose excreted in urine and faeces following oral administration of XEN1101
Time frame: From Screening up to Day 57 post-dose
Time of maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
Terminal elimination half-life for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))
Time frame: From Screening up to Day 57 post-dose
CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)
Time frame: From Screening up to Day 57 post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points
Time frame: From Screening up to Day 57 post-dose
Xenon Pharmaceuticals Inc.
Industry
An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 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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