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

Xenon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 14C-XEN1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04952467

XPF-008-103

2021-000735-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Drug: (14C)-XEN1101

Experimental group

Description:

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

Treatment:

Drug: 14C-XEN1101