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14C-XEN1101

Phase 1

Undisclosed | Small molecule | Other |Xenon Pharmaceuticals Inc.|Trials Updated: Jan 14, 2022

14C-XEN1101 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

14C-XEN1101 clinical trials

14C-XEN1101 · 1 trial · 1 indication

Phase 1 1
NCT04952467Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101Healthy Volunteers
COMPLETED6 Analytics
PHASE1COMPLETED
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
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Study Endpoints

Primary Endpoints

Total radioactivity excreted in urine and faeces following oral administration of XEN1101
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 Endpoints

14C Metabolite profiling in of plasma, urine and feces
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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Drug: (14C)-XEN1101EXPERIMENTALSubjects will receive oral 14C-XEN1101 under fed conditions.

Interventions

NameTypeDescription
14C-XEN1101DRUGSubjects will receive a single oral administration of a capsule containing 20 mg XEN1101
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Eligibility Criteria

Age Range30 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 inves...

Countries:United Kingdom
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Frequently asked questions about 14C-XEN1101

What is 14C-XEN1101?

14C-XEN1101 is a carbon-14 radiolabeled version of the small molecule XEN1101, developed by Xenon Pharmaceuticals Inc. (ticker: XENE). It is used in clinical research to study how the drug is absorbed, metabolized, and excreted in the body. The radiolabel allows researchers to track the drug and its breakdown products.

Who is developing 14C-XEN1101?

14C-XEN1101 is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company that trades under the ticker symbol XENE. Xenon is focused on developing therapies for neurological disorders. The company conducted a Phase 1 trial of 14C-XEN1101 to study its metabolism and excretion.

What phase is 14C-XEN1101 in?

14C-XEN1101 has completed a Phase 1 clinical trial. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial was a single-dose mass balance study conducted in healthy volunteers.

What clinical trials is 14C-XEN1101 in?

14C-XEN1101 has been studied in one completed Phase 1 clinical trial, NCT04952467, titled "Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101." The trial enrolled 6 healthy male volunteers in the United Kingdom and was completed. No active trials are currently listed.

What is 14C-XEN1101 used for?

14C-XEN1101 is used in clinical research to study the mass balance, metabolic profile, and excretion pathways of the drug XEN1101. It is not a therapeutic treatment itself but a radiolabeled tracer used in a Phase 1 trial with healthy volunteers to understand how the body processes the drug.