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

First listed
Jul 7, 2021
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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