Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: 14C-XEN1101


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Body mass index (BMI) of 18.0 to 32.0 kg/m2 Must be willing and able to communicate and participate in the whole study Provide written informed consent Adhere to the specified contraception requirements Key Exclusion Criteria: Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days Evidence of any current infection or an infection within 14 days before study drug administration History of any drug or alcohol abuse in the past 2 years Subjects with pregnant or lactating partners Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded. Confirmed positive drugs of abuse test result Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: (14C)-XEN1101<br>Subjects will receive oral 14C-XEN1101 under fed conditions. | Drug: 14C-XEN1101<br>* Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity excreted in urine and faeces following oral administration of XEN1101 | 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 | From Screening up to Day 57 post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 14C Metabolite profiling in of plasma, urine and feces | 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 | From Screening up to Day 57 post-dose | 
| Pharmacokinetic (PK) data for 14C-XEN1101; Tmax | 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 | From Screening up to Day 57 post-dose | 
| PK data for 14C-XEN1101; Cmax | Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101 | From Screening up to Day 57 post-dose | 
| PK data for 14C-XEN1101; T1/2 | 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 | From Screening up to Day 57 post-dose | 
| Mass balance data for 14C-XEN1101 in urine | CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) | From Screening up to Day 57 post-dose | 
| Mass balance data for 14C-XEN1101 in feces | CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces) | From Screening up to Day 57 post-dose | 
| Plasma whole blood concentration ratios for total radioactivity | Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points | From Screening up to Day 57 post-dose | 
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations |  | From Screening up to Day 57 post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XEN1101, Mass Balance, Phase 1