Recent Updates
Recently added Catalysts

14C-XEN1101

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04952467Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101PHASE1 COMPLETED 6Jul 14, 2021Oct 4, 2021Jan 14, 20221 United Kingdom
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range30 Years — 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
Unlock Eligibility Criteria