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

Xenon Pharmaceuticals Inc.1 site in 1 country6 target enrollmentJuly 14, 2021

ConditionsHealthy Volunteers

Interventions14C-XEN1101

Drugs14C-XEN1101

Overview

Phase: Phase 1
Intervention: 14C-XEN1101
Conditions: Healthy Volunteers
Sponsor: Xenon Pharmaceuticals Inc.
Enrollment: 6
Locations: 1
Primary Endpoint: Total radioactivity excreted in urine and faeces following oral administration of XEN1101
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 14, 2021

End Date

October 4, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Xenon Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Drug: (14C)-XEN1101

Subjects will receive oral 14C-XEN1101 under fed conditions.

Intervention: 14C-XEN1101

Outcomes

Primary Outcomes

Total radioactivity excreted in urine and faeces following oral administration of 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

Secondary Outcomes

Plasma whole blood concentration ratios for total radioactivity(From Screening up to Day 57 post-dose)
Pharmacokinetic (PK) data for 14C-XEN1101; Tmax(From Screening up to Day 57 post-dose)
PK data for 14C-XEN1101; Cmax(From Screening up to Day 57 post-dose)
14C Metabolite profiling in of plasma, urine and feces(From Screening up to Day 57 post-dose)
PK data for 14C-XEN1101; T1/2(From Screening up to Day 57 post-dose)
Mass balance data for 14C-XEN1101 in urine(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)
Mass balance data for 14C-XEN1101 in feces(From Screening up to Day 57 post-dose)