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

NCT04952467 | Completed Phase 1

• 2 other identifiers: XPF-008-1032021-000735-32
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

XEN1101; Mass Balance; Phase 1

Outcome Measures

Primary Outcomes (1)

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

  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

  From Screening up to Day 57 post-dose

Secondary Outcomes (8)

• 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

• PK data for 14C-XEN1101; T1/2

  From Screening up to Day 57 post-dose

• Mass balance data for 14C-XEN1101 in urine

  From Screening up to Day 57 post-dose

Study Arms (1)

Drug: (14C)-XEN1101

EXPERIMENTAL

Subjects will receive oral 14C-XEN1101 under fed conditions.

Drug: 14C-XEN1101

Interventions

14C-XEN1101 DRUG

Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101

Drug: (14C)-XEN1101

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
• Evidence of any current infection or an infection within 14 days before study drug administration
• History of any drug or alcohol abuse in the past 2 years
• Subjects with pregnant or lactating partners
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
• Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Study Director

  Xenon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: July 14, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)