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

NCT ID: NCT04952467

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2021-10-04

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Drug: (14C)-XEN1101

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

Group Type: EXPERIMENTAL

14C-XEN1101

Intervention Type: DRUG

Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Interventions

14C-XEN1101

Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Intervention Type: DRUG

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
• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xenon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Xenon Pharmaceuticals Inc.

Locations

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

2021-000735-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XPF-008-103

Identifier Type: -

Identifier Source: org_study_id