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14C-XEN1101

Phase 1

Healthy Volunteers | Small molecule | Other |Xenon Pharmaceuticals Inc.|Last Updated: Jan 14, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

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
Healthy Volunteers
NCT049524676
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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 used for?

14C-XEN1101 is an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of XEN1101, developed for research purposes to track the drug's absorption, distribution, metabolism, and excretion in the body. It is not intended for therapeutic use in patients.

Who makes 14C-XEN1101?

14C-XEN1101 is developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XENE. The company is conducting clinical research on this compound to understand its pharmacokinetic properties.

What phase is 14C-XEN1101 in?

14C-XEN1101 is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 6 healthy male volunteers. The study was conducted in the United Kingdom and focused on mass balance recovery and metabolite profiling.

What clinical trials is 14C-XEN1101 in?

14C-XEN1101 has one completed clinical trial, registered as NCT04952467. The study, titled 'Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101,' enrolled 6 healthy male volunteers aged 30 years and older in the United Kingdom.

Is 14C-XEN1101 the same as XEN1101?

14C-XEN1101 is a radiolabeled version of XEN1101, where a carbon-14 isotope is incorporated into the molecule. This labeling allows researchers to track the compound's fate in the body during clinical studies. It is used as a research tool to study the pharmacokinetics of XEN1101.