Healthy Volunteers
Conditions
Keywords
XEN1101, Mass Balance, Phase 1
Brief summary
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.
Interventions
DRUG14C-XEN1101
Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
Sponsors
Xenon Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radioactivity excreted in urine and faeces following oral administration of XEN1101 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) data for 14C-XEN1101; Tmax | 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 |
| PK data for 14C-XEN1101; Cmax | 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 |
| PK data for 14C-XEN1101; T1/2 | 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 |
| 14C Metabolite profiling in of plasma, urine and feces | 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 |
| Mass balance data for 14C-XEN1101 in feces | From Screening up to Day 57 post-dose | CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces) |
| Plasma whole blood concentration ratios for total radioactivity | From Screening up to Day 57 post-dose | Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points |
| 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 | — |
| Mass balance data for 14C-XEN1101 in urine | From Screening up to Day 57 post-dose | CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine)) |
Countries
United Kingdom
Outcome results
None listed