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

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT04952467
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 14C-XEN1101 — DRUG
    Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Study Details

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.

Key Dates

Start date
Jul 14, 2021
Status verified
Jan 2022
Primary completion
Oct 4, 2021
Completion
Oct 4, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Drug: (14C)-XEN1101
    Subjects will receive oral 14C-XEN1101 under fed conditions.

Primary Outcome Measure

Total radioactivity excreted in urine and faeces following oral administration of XEN1101 [ Time Frame: From Screening up to Day 57 post-dose ]

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